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76–576 2013

PREMATURITY AND INFANT MORTALITY: WHAT 

HAPPENS WHEN BABIES ARE BORN TOO EARLY? 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

MAY 12, 2010 

Serial No. 111–121 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 


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SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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C O N T E N T S 

Page 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 1 

Hon. Ed Whitfield, a Representative in Congress from the Commonwealth 

of Kentucky, opening statement ......................................................................... 2 

Hon. Lois Capps, a Representative in Congress from the State of California, 

opening statement ................................................................................................ 3 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 4 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 5 

Hon. John Shimkus, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 6 

Hon. Janice D. Schakowsky, a Representative in Congress from the State 

of Illinois, opening statement .............................................................................. 12 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 13 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 14 

Hon. Christopher S. Murphy, a Representative in Congress from the State 

of Connecticut, opening statement ..................................................................... 15 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, prepared statement .......................................................................... 16 

Hon. Kathy Castor, a Representative in Congress from the State of Florida, 

opening statement ................................................................................................ 16 

Hon. Bruce L. Braley, a Representative in Congress from the State of Iowa, 

opening statement ................................................................................................ 18 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, prepared statement ........................................................................... 113 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, prepared statement .................................................................................. 117 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 118 

WITNESSES

William Callaghan, MD, MPH, Senior Scientist, Maternal and Infant Health 

Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and 

Prevention ............................................................................................................. 19 

Prepared statement .......................................................................................... 21 

Answers to submitted questions ...................................................................... 155 

Catherine Spong, MD, Branch Chief, National Institute of Child Health and 

Human Development, National Institutes of Health ........................................ 32 

Prepared statement .......................................................................................... 35 

Answers to submitted questions ...................................................................... 155 

Alan R. Fleischman, MD, Senior Vice President and Medical Director, March 

of Dimes Foundation ............................................................................................ 61 

Prepared statement .......................................................................................... 64 

Answers to submitted questions ...................................................................... 157 

Charles S. Mahan, MD, FACOG, Dean and Professor Emeritus, USF College 

of Public Health, Lawton and Rhea Chiles Center for Healthy Mothers 

and Babies ............................................................................................................ 74 

Prepared statement .......................................................................................... 77 


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VI 

Hal Lawrence, MD, Vice President, Practice Activities, American College 

of Obstetricians and Gynecologists ..................................................................... 81 

Prepared statement .......................................................................................... 83 

SUBMITTED MATERIAL

Statement of Craig Rubens of Seattle Children’s Hospital, submitted by Ms. 

Schakowsky .......................................................................................................... 8 

Letter of May 10, 2010, from Health and Human Services to the House 

and Senate, submitted by Ms. Capps ................................................................. 123 

Articles by the American Association of Prolife Obstetricians and Gynecologists ................................................................................................................. 127 

Testimony of Dr. Paula Braveman ......................................................................... 143 

Prepared material of Dr. Nicholas Eberstadt ........................................................ 147 


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PREMATURITY AND INFANT MORTALITY: 

WHAT HAPPENS WHEN BABIES ARE BORN 

TOO EARLY? 

WEDNESDAY, MAY 12, 2010 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 3:05 p.m., in Room 

2123 of the Rayburn House Office Building, Hon. Frank Pallone, 

Jr. [Chairman of the Subcommittee] presiding. 

Members present: Representatives Pallone, Green, Capps, Schakowsky, Barrow, Christensen, Castor, Murphy of Connecticut, 

Braley, Shimkus, Whitfield, Pitts, Murphy of Pennsylvania, Burgess, Blackburn and Gingrey. 

Staff present: Ruth Katz, Chief Public Health Counsel; Sarah 

Despres, Counsel; Jack Ebeler, Senior Advisor on Health Policy; 

Robert Clark, Policy Advisor; Stephen Cha, Professional Staff 

Member; Alvin Banks, Special Assistant; Allison Corr, Special Assistant; Camille Sealy, Fellow; Ryan Long, Minority Chief Counsel, 

Health; and Aarti Shah, Minority Counsel, Health. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. The meeting of the Health Subcommittee is called 

to order, and today we are having a hearing on ‘‘Prematurity and 

Infant Mortality: What Happens When Babies Are Born Too 

Early.’’ I will recognize myself for an opening statement initially. 

The consequences of premature births and infant mortality, both 

the causes and consequences, need to be examined because this is 

an important but complicated public health issue for which much 

is still unknown. According to the Centers for Disease Control and 

Prevention, each year more than a half-million babies in the 

United States, or one in every eight, are born prematurely. This 

statistic is up 20 percent from 1990 and we are just starting to see 

a decline. Despite the recent decrease, preterm birth remains a 

pressing health issue which deserves ample attention as it is the 

greatest risk factor for infant mortality and contributes to a host 

of acute and chronic conditions. 

While much advanced research has been conducted and continues today, researchers are still trying to understand why 

preterm labor occurs. However, we do know that there is a set of 


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factors that put women at higher risk of having a premature baby. 

Some known factors include carrying more than one baby, having 

a previous preterm birth, high blood pressure and diabetes. In addition, we know that there are also external factors that occur either alone or in combination with other individual characteristics, 

and these include age, race, poverty, marital status, stress, environmental chemicals and many others. I am interested to hear 

from our witnesses today how these factors intertwine and what we 

can do moving forward to limit their effects. 

While not directly linked to prematurity, I am particularly interested to hear today about the prevalence of stillbirths and sudden 

unexpected infant death, or SUID, within the infant mortality rate 

in the United States. Like preterm birth, stillbirth, there are some 

risk factors and causes such as maternal medical conditions, fetal 

factors, umbilical cord problems and placental abnormalities. However, despite these known risk factors, there is no known cause for 

as many as half of all stillbirths, leaving many parents without answers to the reasons for these deaths. No parent should have to endure the pain of losing a child, especially without knowing why 

that child was taken from them so soon. 

And I have introduced a bill called the Stillbirth and SUID Prevention Education Awareness Act, which would improve data collection and education so we can better understand the cause of 

these deaths and help parents get the information and answers 

they want to prevent. The bill would also fund investigations to finally provide some answers by creating a national registry to help 

researchers understand the scope and impact of these tragedies. By 

understanding the causes of death, we can prevent these tragedies 

in the future, and we want every child to have the chance to grow 

up healthy. 

In my opinion, infant mortality is a public health problem that 

needs the attention of the subcommittee, so I would like to thank 

all of our witnesses for being here today. I know other members 

have raised this. This is not a legislative hearing on my bill but 

an oversight hearing essentially to find more about these issues 

and to determine whether or not we should move forward with 

some legislation. 

At this time I guess we will go to Mr. Whitfield. The gentleman 

from Kentucky is recognized. 

OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY 

Mr. WHITFIELD. Well, Mr. Chairman, thank you very much, and 

I certainly want to thank the panel of witnesses for being here 

today on this very important subject. 

As the chairman said, half a million babies are born preterm in 

the United States each year, and the Centers for Disease Controls 

states that preterm births are the greatest risk factor for infant 

mortality with over one-third of all infant deaths being attributed 

to preterm births, and according to the Institute of Medicine, there 

is no one cause of preterm birth, rather, there are socioeconomic, 

biological and environmental factors that all can lead to prematurity. 


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One area that I am particularly interested in and I think it is 

very important that we explore is the reporting methods used by 

different countries. I think it is important that we all have the 

same reporting standards so that we can really determine what the 

health statistics are as they relate to infant mortality. According to 

the CDC, in 2005, the latest year that the international ranking is 

available, the United States ranked 30th in the world in infant 

mortality behind most European countries, but there is not one 

consistent reporting standard for many of these countries and I do 

feel it is important that we establish a uniform standard. 

I look forward to our witnesses today and the information that 

they will provide us, and I yield back the balance of my time. 

Mr. PALLONE. Thank you, Mr. Whitfield. 

Next is our vice chair, Ms. Capps, the gentlewoman from California. 

OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mrs. CAPPS. Thank you, Chairman Pallone, for holding this extremely important hearing, to our witnesses for being here today, 

and to the fact that we have this bill being discussed. We have 

quite a few health professionals in the audience and we have a 

group on the Hill visiting of CARE, an international organization 

with very strong ties to this legislation as well. 

Many people would just assume that the United States being as 

advanced as it is doesn’t have significant infant mortality rates or 

that everyone has access to high-quality prenatal care, it is kind 

of a given, and that prevention of prematurity or other complications is not a serious situation. But the truth is, and that is why 

I am so thankful that we are having this hearing today, the United 

States lags far behind other industrialized nations in infant mortality rates, and I might add, maternal mortality rates as well. 

So why is this happening in our country? First and foremost, we 

have a problem of access. Fortunately, we have now new health reform law which puts into place several measures that will improve 

the health of our mothers and of our infants. This will happen 

through eventually universal coverage, training of more health care 

providers, greater emphasis on prevention and wellness through 

grants and other incentives but there is always more than we can 

and should be doing to ensure safe pregnancies and safe babies. 

For example, I was proud to join in the recent Capitol Hill 

launch of a new service called Text for Baby, and this is done with 

the Congressional Caucus for Women’s Issues, and Text for Baby 

is a new, free mobile health information service designed to promote maternal and child health among underserved populations 

through simple text messaging, and I plan in my Congressional district to find a way to allow some of my constituents to see this program demonstrated, and I hope that we will see more programs 

like this to get funded through the new mandatory spending which 

are put in place for prevention and wellness. 

The other important need is to better gather data and conduct 

further research so that we can develop a more coordinated and 

comprehensive strategy. I am proud to cosponsor two important 

pieces of legislation that do address infant health research and 


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education. One is the Birth Defects Prevention, Risk Reduction and 

Awareness Act, and this is sponsored by Rosa DeLauro, and then 

there is also your own bill, Mr. Chairman, SID prevention, Stillbirth and SUID Prevention Education and Awareness Act, sponsored by Chairman Frank Pallone. Having a healthy pregnancy 

and a healthy baby shouldn’t be determined by the color of your 

skin, where you live or how much money you earn. 

I am eager to hear from our witnesses today to see what steps 

we can take to reduce infant mortality and morbidity for all families in the United States. I pledge my continued support to make 

pregnancy and childbirth safe and healthy for all moms and their 

newborns, and I yield back. 

Mr. PALLONE. I thank the gentlewoman. 

The gentleman from Pennsylvania, Mr. Pitts. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Mr. PITTS. Thank you, Mr. Chairman. 

As we will hear, prematurity is the number one risk factor in infant mortality, and preterm birth rate in the United States has 

been on the rise for the past few decades. Not only is the potential 

for mortality a risk for preterm infant but these babies could also 

face a wide range of health problems, some lifelong, such as breathing and respiratory problems, vision problems, increased susceptibility to infection and intellectual disabilities, to name a few. 

While we do not know precisely why more babies are being born 

preterm, one thing we do know is that we need medical professionals to care for women and their babies throughout pregnancy, 

and this brings us to the issue of medical liability. One of our witnesses on the second panel, Dr. Hal Lawrence, is here representing 

the American College of Obstetricians and Gynecologists, or ACOG. 

ACOG’s 2009 survey on professional liability sought to determine 

how medical liability legislation and medical liability insurance 

issues affect the practices of its members. Some of the survey’s statistics and conclusions are astounding. This comes from the survey’s executive summary: ‘‘Of the survey respondents who reported 

making changes to their obstetric practice because of insurance 

portability or availability or both, 191⁄2 percent reported increasing 

the number of Cesarean deliveries. Additionally, 21.4 percent decreased the number of high-risk obstetric patients, 10.4 percent decreased the number of total deliveries and 6.5 percent stopped 

practicing obstetrics altogether.’’ When survey respondents were 

asked about making changes to their obstetric practice as a result 

of the risk or fear of professional liability claims or litigation, here 

were the results: 30.2 percent decreased the number of high-risk 

obstetric patients, 29.1 percent reported increasing the number of 

Cesarean deliveries, an additional 13.9 percent decreased the number of total deliveries and 8 percent stopped practicing obstetrics 

altogether. 

Over my years in Congress, I have heard from multiple OB/ 

GYNs who due to medical liability climate could no longer afford 

to practice in Pennsylvania and were either retiring early, no 

longer delivering babies or moving their practices to nearby DelaVerDate Mar 15 2010 02:39 Feb 16, 2013 Jkt 076576 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 E:\HR\OC\A576.XXX A576

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ware. In just the city of Philadelphia and four surrounding counties 

in southeastern Pennsylvania, where I am from, 18 hospitals have 

closed their maternity wards since 1997, and a 19th will end obstetric services next month. Since 2001, southeastern Pennsylvania 

has lost 30 percent of its practicing obstetricians, and according to 

the chief of obstetrics at Hahnemann Hospital, Dr. Owen Montgomery, Lloyds of London calls southeastern Pennsylvania the 

worst liability market in the world. 

Medical liability is a serious problem with direct consequences 

for patients, particularly for mothers and their unborn children, 

and in recently passed health care law, what did we do to ameliorate this situation? We funded state demonstration projects on 

medical liability. We have already had two large and quite successful demonstration projects on this issue. Their names are California and Texas. We don’t need more studies. What we need is 

real reform, and in this case the new health care reform law does 

not deliver. 

I yield back. 

Mr. PALLONE. I thank the gentleman. 

Next is the gentleman from Texas, Mr. Green. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman, for holding the hearing 

today on infant mortality. 

According to the CDC, the United States ranks 28th among developed countries in infant mortality with 6.9 deaths per 1,000 live 

births. Among the leading causes of infant mortality in the United 

States, birth defects, preterm birth, low birth weight, sudden infant 

death syndrome and respiratory distress syndrome, preterm birth 

and low birth weight are the only factors that haven’t declined. According to the March of Dimes, who we will hear from today, insurance plans for large employers paid an average of $64,713 to cover 

the cost of inpatient and outpatient medical care and prescriptions 

for one preterm newborn and mother. That figure doesn’t include 

the cost of potential re-hospitalization and long-term care and services. The Agency for Health Care and Research and Quality estimated in 2005 that on a national scale private insurance and Medicaid each paid about $7.4 billion to cover preterm infants’ inpatient hospital charges. 

In Texas, Medicaid covers about half of all births annually. The 

Texas Health and Human Service Commission reports Texas Medicaid spent $408 million in 2007 on hospital costs associated with 

preterm births. Texas and our district in particular still leads the 

Nation in percentage of uninsured residents. Texas also has the 

third highest rate of births to teen mothers nationally at 63.1 per 

1,000. From 1990 to 2006, CDC National Center for Health Statistics showed the rate of preterm birth in Texas increased 22 percent 

from 11.2 percent of live births in 1990 to 13.7 percent in 2006. The 

State saw a slight decrease from 2006, a 1 percent decrease from 

2006–2007. In Texas, 18.7 percent of live births to African American women are preterm compared to 12.7 percent for Anglo 

women, 13.3 percent for Hispanic women and 11.3 percent for 

Asian women. 


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One cause that has been pointed to as a potential cause of 

preterm birth is induced or cesarean births at 34 to 36 weeks due 

to a miscalculation in the gestational age of the baby. At the Tex 

Med Conference in 2009, the Texas Medical Association and House 

of Delegates adopted a recommendation to support the prevention 

of preterm births caused by delivering a baby early by physicians 

and others who attend at the delivery of infants. The recommendation presented by the TMA’s committee on maternal and prenatal 

health grew out of the March of Dimes’ concern that some premature births may occur without good medical justification such as 

request or convenience of the mother or because of incorrect calculation of the gestational age of the fetus. I am hoping the witnesses today will address this topic. 

Again, I want to thank all our witnesses for being here and appreciate the time, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Green. 

Our ranking member, Mr. Shimkus. 

Mr. SHIMKUS. First of all, Mr. Chairman, thank you. I am going 

to ask unanimous consent that all opening statements are going to 

be submitted for the record. We have got competing hearings, and 

I am not sure everyone is going to be able to make it up. 

Mr. PALLONE. Without objection, so ordered. 

Mr. SHIMKUS. I also want to apologize for not being here punctually. The Appropriations Committee is dealing with some testimony. Kristin Fitzgerald, who testified before our committee, 

whose husband—— 

Mr. PALLONE. Well, I was told you were here before me. 

Mr. SHIMKUS. I was, but then I left. So that is my apology. 

The last thing. I want it on the record, we asked for someone to 

testify on the second panel, a Republican witness. They did not get 

their testimony in on time. I have been very hard on the Administration for not getting their testimony in on time so I asked the 

chairman to disinvite the Republican member of the second panel, 

which we ended up doing, and I think that is appropriate and I just 

want to take all the burden—— 

Mr. PALLONE. It is going to make it harder for me. I am going 

to have to make sure the Administration witnesses are on time 

now. 

OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Mr. SHIMKUS. You have to lead by example. That is the key, Mr. 

Chairman. 

Thank you, Mr. Chairman. Any time a child a born is special. Although preemie births make it challenging, I have been able, just 

like many members, to go through hospitals and see great facilities 

that are doing all they can to save the lives of premature babies. 

We have passed the PREEMIE Act a couple years ago, and so 

hence the analysis of data and the follow-up that is occurring here. 

We do have issues with making sure—no one is going to dispute 

that we are not as good as we could be in this country. We want 

to make sure we are comparing apples to apples versus apples to 

oranges, and I do this in other committees. In Telecom, I hate it 

when we are compared to Liechtenstein on broadband access. So 


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we just make sure that when we want to compare apples to apples, 

we are doing—other countries may not consider a live birth what 

we consider a live birth, and so let us throw that out there and just 

get clear data so if we are going to do some comparisons, we are 

going to do some comparisons. 

As always, I also want to make sure that as ranking member I 

continue to stay on record calling for additional hearings on the 

health care law. We just had a CBO report out this week. It says 

oh, we made a mistake, there is $110 billion in additional costs. 

That is all part of that calculation that we were told that this was 

going to save money. So we know that those stats were not correct. 

We think it is time to start talking about this and we think it is 

time, especially on this issue, the Medicaid issue for the poor, as 

we add 18 million more people to the Medicaid rolls without funding, who gets left out? And I think the very people we are talking 

about today, the poor mothers with no care. Because what docs will 

do, in Illinois we are $12.5 billion in debt. Medicaid is paying 30 

cents on the dollar 280 days late. Thirty cents on the dollar, 280 

days late. And the doctors who are servicing Medicaid patients, 

some are just writing it off and some are going to start limiting 

that access to care, and this is the issue that has also been raised 

by the Administration and Secretary Sebelius when she said we 

need more docs, we need more primary care physicians, and guess 

what? This health care law does nothing to address more providers. 

So we will continue the clarion call to say let us have some hearings on the law. 

I am going to end with this. An individual who recently served 

in my staff left and went to Colorado and now has been working 

in the private sector. She sent me an e-mail, and as a direct result 

of the passage of this health care law, her insurance company folded. Her child, who had a preexisting condition, now has no coverage. As a direct result of this law, she cannot purchase insurance 

for her family because of a child with a preexisting condition. Now, 

folks, that is something we can fix. We can have a hearing today. 

We can draft legislative language tomorrow and we can move it to 

the floor next week. Why do we accept a gap in this period of time 

when we are allowing folks to not have coverage based on preexisting conditions when we were promised that that would not be 

the case? 

So Mr. Chairman, hopefully you will raise this issue to the full 

committee chairman. I know he is busy down in the Oversight and 

Investigation hearing. But we will continue to say I think it is time 

to start talking about the effects of this health care law, and I yield 

back my time. 

Mr. PALLONE. Thank you. 

The gentlewoman from Illinois, Ms. Schakowsky. 

Ms. SCHAKOWSKY. Thank you. 

First, at the request of our Energy and Commerce Committee 

colleague, Jay Inslee, I ask unanimous consent to enter into the 

record a statement from Seattle Children’s Hospital. 

[The information follows:] 


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tjames on DSK6SPTVN1PROD with HEARINGInsert graphic folio 13 76576A.001

Committee on Energy and Commerce 

Subcommittee on Health 

Hearing on May 12, 2010 

"Prematurity and Infant Mortality: 

What Happens When Babies are Born Too Early?" 

Written Testimony Submitted by 

Craig E. Rubens, MD, PhD 

Executive Director of GAPPS, an initiative of Seattle Children's 

Prematurity impacts half a mHlion families throughout our country evelY year, and is a 

leading cause of infant mortality. Babies born before 37 completed weeks of pregnancy 

have increased risks for infections. cerebra! palsy, and respiratory, vision, hearing, and 

developmental problems. U.S. rates have risen by about a third since 1981 and 

significant racial and ethnic disparities persist. 

A large discrepancy also exists between related costs and research: preterm birth is a 

leading U.s. health care expenditure ($26B in 2005), yet perinatal health research ranks 

only 54th in NIH funding. 

We commend the Chairman and Ranking Member for calling this on prematurity 

The first step in moving forward to reduce prematurity rates is awareness and open 

discussion. GAPPS recommends three essential actions that Congress could take now 

to address prematurity and the associated consequences and costs, 

About GAPPS, an initiative of Seattle Children'S 

Seattle Children's hospital serves patients from four slates: Washington, Alaska, 

Montana and Idaho. Between 40-49% of patients admitted to Seattle Children'S 

Neonatal Intensive Cafe Unit are born prematurely. Seattle Children's idenilfied 

prematurity as a research priority and, in 2007, launched the Global Alliance to Prevent 

Prematurity and Stillbirth (GAPPS) to address these two devastating health problems. 

Prematurity and stillbirth share many common causes, and require interdisciplinary 

efforts to solve, 

In February 2010, GAPPS published the Global report on preierm birth & stillbirth: the 

foundation for innovative solutions and improved outcomes with BioMedCentral 

Pregnancy and Childbirth (available at www.gapps.org/resources).This report provides 

a comprehensive assessment of what is known, what needs to be known and what can 

be done to improve pregnancy outcomes. It contains seven articles: (1) definitions, 

description of lhe burden and opportunities to improve data, (2) discovery science, (3) 

the effectiveness of interventions, (4) delivery of interventions, (5) advocacy barriers and 

opportunities, (6) ethical considerations, and (7) mobilizing resources to accelerate 

innovative solutions (Global Action Agenda). 

The Global Action Agenda was developed by more than 200 stakeholders who attended 

Ihe 2009 GAPPS International Conference on Prematurity and Stillbirth, which was coconvened with the Bill & Melinda Gates Foundation, March of Dimes, PATH, Save the 
9 


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Children, UNICEF, and the World Health Organization. The Action Agenda is a comprehensive set of recommendations that include short-, intermediate- and long-term 

Tlilestones, and success metrics .. Most of the milestones are set to be achiev~)d by 2015 

3efow are the key findings from the report and recommendations from the Action 

tl,genda. 

Interventions are strategies to diagnose, treat, and prevent prelerm birth and related 

maternal, newborn, and child health problems. There are only two interventions that 

have been shown to prevent preterm birth, and 11 to improve survival and care of 

preterm newborns in low-resource settings. We must balance the research paradigm to 

address upstream, basic science to better understand causes and prevent preteI'm birth. 

Only 2 interventions exist to prevent preterm birlh 

it Smoking cessation 

.. Progesterone 

11 interventions exist to improve survival of preterm newboms 

.. Prophylactic steroids in pre term labor 

.. Antibiotics for preterm labor with premature rupture of membranes 

" Delayed cord clamping 

.. Vitamin K supplementation at delivery 

Community management of neonatal sepsis and pneumonia (where facility 

referral is unavailable) 

.. Resllscitation with room air 

.. Hospital-based kangaroo mother care 

.. Early breastfeedlng 

.. Thermal care to prevent hypothermia 

,. Surfactant therapy for respiratory distress syndrome 

2 
10 


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.. Application of continued distending pressure 10 the lungs for respiratory distress 

syndrome 

We can save lives and reduce prematurity, but we urgently need more action and 

resources to better understand the causes of prematurity, and to guide development of 

cost-effective interventions, For the first time ever, experts have agreed to a 

comprehensive, evidence-based approach to SOlving this complex health problem, 

In the Global Action Agenda that was developed by more than 200 stakeholders at the 

2009 International Conference on Prematurity and Stlllbfrth, globa! health leaders 

outiined collaborative strategies to achreve four key goals: 

Increase awareness and understanding of the magnitude of/he problem 

Many policymakers are unaware of the magnitude of the health problems caused 

by preterm birth, and their relationships to maternal, child and adult health, 

Others have been aware of the problem, but have not known what to do, 

Close the research gaps· 

The biology of pregnancy and childbirth is poorly understood, as are the causes 

of pre!erm birth and stillbirth. Additionally, it is difficu!t to calculate the magnitude 

of lhe problem as there are no global standards for dala collection, 

Supporl the discovery, development and delivery of interventions 

More research is needed 10 determine which interventions are most effective, 

Effective interventions that are already available In low-resource settings should 

be promoted for scale-up, Effective interventions that are only available in 

income countries should be adapted and evaluated for effectiveness in 10livresource settings. 

Increase resources for research and implementation 

Significant funding, ('''Ommitment and a coordinated effort are needed to reduce 

,nr?I?.rm births, 

Why we understand cancer better than pregnancy 

Through a coordinated and focused research agenda led by the National Cancer 

Institute, scientists have made great strides in understanding and treating cancers. This 

has largely been accomplished through widespread collection and distribution of tumor 

specimens for research, Similarly, we need a coordinated and focused research effort to 

understand prematurity, As has been done for cancer, we need hiobanks that collect 

maternal data linked to biological specimens (e,g,. blood, urine, placental tissues) so that 

scientists can utilize the new tools of syslems biology to understand normal and 

abnormal pregnancy outcomes, The tools to do this now exist and have led to exciting 

advances in cancer treatment and cures--but are barely being utilized for the study of 

prematurity, 

3 
11 


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What can congross do now? 

Congress can invest in a national campaign to significanlly reduce preterm births and 

infant mortalities in the United States. Three essential action items are outlined below, 

1. Prioritize basic and translational science efforts on pregnancy, fetal development, 

and newborn health 

2. Expand efforts to attract scientists to the fields of obstetrical and newborn 

research 

3, Authorize a national campaign to develop national centers of excellence for the 

study of prematurity and infant mortality 

One in eight babies is born too soon in the United States and, for the most part, we don't 

know why, We urgently need better data and tools, and more champions and resources, 

We are grateful that the Committee on Energy and Commerce: Subcommittee on Health 

recognized the importance of prematurity in today's hearing, GAPPS is forging a 

collaborative effort toward achieving common goals to prevent preterm birth. We have a 

unique opportunity to move lhe prematurity agenda forward, We look forward to working 

with the Subcommittee to raise visibility for these critical issues in order to fuel 

investments, accelerate innovative research and interventions, and promote effective 

health policies that will improve maternal, newborn and child health. 

Sincerely, 

Craig E. Rubens 

Executive Director 

GAPPS, an initiative of Seattle Childrens 

4 
12 

Mr. PALLONE. Without objection, so ordered. 

OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Thank you. 

The creation of the—oh, first let me say that fortunately the 

health care bill that we passed does allow for children with preexisting conditions requires that they be eligible for health care 

and not be excluded. 

The creation of the Millennium Development Goals has placed 

significant attention on maternal and infant mortality rates within 

the international community. The aim is to drastically reduce these 

rates by 2015, and we have made visible, albeit slow, progress toward these goals, but as we work with our international partners 

to reduce infant and maternal deaths in some of the most challenging places in the world, I am constantly reminded that we face 

a health disparities crisis right here at home. In fact, one out of 

eight U.S. babies is born prematurely. 

Gwen Moore, our colleague and vice chair of the Congressional 

Caucus for Women’s Issues, represents Milwaukee, Wisconsin, and 

she often talks about the absolutely abhorrent health disparities 

that are so evident in the infant and maternal mortality rates in 

her district. Thirty-three out of every 100,000 African American 

women died from pregnancy-related complications in 2006 compared to fewer than 10 among white women during that same period. There are studies showing that even when researchers control 

for socioeconomic factors, health risks like smoking or chronic disease and geographic locations, a poor white woman is more likely 

to have a healthy childbirth than a wealthy African American 

woman. 

So most of our witnesses today have referenced this disparity 

and have pointed to reasons why these statistics might bear out 

the way that they do but what I am left with when looking at the 

collective testimony is that it doesn’t seem that we really know why 

there is such a discrepancy in the rates of premature births, birth 

defects and infant mortality and maternal mortality across different populations. Is it an access to health care issue? Is it culture? Is it socioeconomic status or location or the number of children born to one mother? Why is it that African American women 

are 1–1/2 times more likely to deliver a preterm infant compared 

to a white woman? I hope we will get some of those answers today. 

While I am concerned about the plateau that we seem to have 

hit in reducing infant mortality in this country in the 21st century, 

I do know that there is a lot of interest and a lot of collaboration 

aimed at bringing healthy pregnancies to healthy term. Congresswoman Capps mentioned a very interesting and innovative program, Text for Baby, which is a collaborative effort among the Department of Health and Human Services, White House Office on 

Science and Technology and seven major corporations, a public-private partnership to work with at-risk expecting moms. So you go 

to text baby, b-a-b-y or b-e-b-e, at 511411, and at-risk young 

women can receive text messages reminding them to schedule a 


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prenatal visit or get a flu shot or avoid drugs and alcohol, et cetera. 

One small step. 

I look forward to hearing the testimony today and I yield back, 

and thank you, Mr. Chairman. 

Mr. PALLONE. I thank the gentlewoman. 

The gentleman from Pennsylvania, Mr. Murphy. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. MURPHY of Pennsylvania. Thank you, Mr. Chairman. 

Years ago, before I ran for the State Senate, I practiced as a psychologist at Magee Women’s Hospital in Pittsburgh and followed up 

infants in the newborn intensive care unit. There was a moment 

when I was seeing one of the babies there, very premature, very 

small, transparent skin, hooked up to all sorts of equipment, probably not much bigger than my hand, and another baby born addicted to crack cocaine, and I remember saying to the nurse, I have 

had enough of this, I can’t put up with this anymore. She said well, 

are you going to run for office and change the system, and I said 

sure. So here I am. The system still has problems, and I want to 

point out how I hope the scope of this hearing actually expands so 

we can deal with these problems. 

Some years ago when we looked at murder rates in this country 

as declining, people looked upon that as a reason either to give 

their community a pat on the back or a kick in the rear because 

their murder rates were either going up or down. One factor that 

was not computed into that was the access to paramedics and a 

critical-care hospital, which was making a difference in life and 

death and of course reducing rates of murder because some people 

didn’t die. It is important that Congress at that time and this time 

does not misread statistics and we get accurate information on a 

number of things and that I suggest is not just mortality but longterm developmental outcome. It is extremely important. I hope this 

is something the witnesses can provide today with this. 

We will take about a number of epidemiological issues and I hope 

we don’t just caught up in which nation wins the contest of the 

lowest mortality rate because for me, that is not valid information 

at all. We need accurate information of what exactly happens. We 

need to know maternal factors, external factors. Is it income, education, family issues? Is it other factors such as maternal smoking, 

weight gain or loss, nutrition, drug use, age, trauma, complications 

during pregnancy, race? Are there medical issues we need to know 

about? Is it infection rates, prenatal care, access to level 3 nurseries, access to developmental intervention, levels of training of 

neonatologists, pediatricians, family physicians, schools, other educational institutions and statistical analysis to making sure that 

the definition of each one of these is the same between communities and between nations. 

I might add this, that over the years of the children that I have 

seen born premature or very premature, it is interesting to me now 

as I go through in going back to visit communities and inevitably 

some parent will come up to me and introduce their child to me 

who I took care of and who is—when they were very, very young. 


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In many cases the child is successful, working, they introduce me 

to their own children. In addition to not making me feel so young 

when I see that happening, it also makes me very proud that when 

you surround people with good quality medical care and tertiary 

care, good NSU care, that is a very important factor. 

I know the research I did on persistent pulmonary intervention 

in newborns, of all the factors we looked at, what was one of the 

most significant factors relating also to seizure disorders and infarcts and developmental outcome, had to do with where the child 

was cared for, how close they were to a level 3 nursery and not just 

the other medical care around. This is so extremely important. I 

want to make sure that any funding that Congress looks at or any 

change of policy directly addresses these issues. Rather than just 

saying let us throw money at this issue and make sure we have 

some there, let us make sure we are doing a critically good job, and 

I hope that the witnesses will provide this Congress with this information. We want to do it right but it is a matter of just doing more 

than comparing us to other nations. 

With that, I yield back, Mr. Chairman. 

Mr. PALLONE. Thank you. 

The gentleman from Georgia, Mr. Barrow. 

Mr. BARROW. I thank the Chair, but in the interest of the witnesses’ time, I will waive an opening. 

Mr. PALLONE. Thank you. The gentleman reserves. 

The gentleman from Georgia, Mr. Gingrey. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Mr. Chairman, thank you, and thank you for calling this hearing. Obviously as a physician member of the House, 

I am extremely interested in the subject, having practiced and delivered babies for 31 years. 

You know, what concerns me most when I hear that CDC report 

going back to 2005 that ranks the United States 30th in the world 

in regard to infant mortality, which as we all know is the death 

of a child within the first year of life, and you start scratching your 

head and say well, how could that be when we spend two and a 

half times as much per capita on health care in this country, and 

clearly with all corrections that need to be done in making those 

comparisons, our prematurity rate and our infant mortality rate is 

too high and we should make every effort to do something about 

that, and I really look forward to both panels of witnesses today 

to help us understand how we can do that. 

But when you compare our country to countries that count a 

death in the first 24 hours of life as a miscarriage essentially, that 

is not a fair comparison. Forty percent of premature infants in our 

country, many of them immature, born before 32 weeks, not just 

before 37 weeks, many of them are going to die in the first 24 

hours of life, in fact 40 percent. So when some countries don’t even 

count those as live births and others say well, you know—I think 

France does this—any child that is less than 500 grams is not considered a live birth or other countries that say any child that is less 

than 30 centimeters in length is not considered a live birth. We 

have got to as other colleagues have mentioned compare apples to 


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apples to get a true meaning and understanding, and I am not 

going to say these statistics were necessarily used to make a point 

that we need to have a universal health care system or singlepayer system or pass the Senate bill 3590 that we did here just a 

month ago but let us use the right statistics. It is very important 

that we do that. 

As we look at matters related to obstetric and pediatric care, I 

think we should not overlook the need to enact meaningful tort reform to help address a shortage of OB/GYN providers in markets 

all across the country. I believe that Republicans and Democrats 

together can work on this issue, one that I think most Americans 

support. 

And Mr. Chairman, I want to make one last point. I realize my 

time is up. But I want to welcome Dr. Lawrence from the American 

College of OB/GYN, who is going to be on the second panel. Dr. 

Lawrence as a practicing OB/GYN for more than 30 years, I am interested in hearing more about your MOMS Initiative. It is my 

hope that efforts like yours might improve both maternal and infant health in our country, and I would like to find out ways that 

we can work together in this area. 

Thank you, Mr. Chairman, and with that I will yield back. 

Mr. PALLONE. Thank you, Mr. Gingrey. 

Next is the gentleman from Connecticut, Mr. Murphy. 

OPENING STATEMENT OF HON. CHRISTOPHER S. MURPHY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF CONNECTICUT 

Mr. MURPHY of Connecticut. Thank you, Mr. Chairman, for calling this hearing today. 

I recently met with a constituent of mine, Arnold Goodman of 

Avon, Connecticut, whose wife died during childbirth, and he explained to me the causes of maternal mortality such as multiple 

Cesarean sections, increased age and obesity that are also risk factors for premature birth. He told me that the gaps in the research 

and the lack of uniform reporting that perpetuate both maternal 

mortality and premature birth and infant mortality still persist, so 

I am interested here today in learning more about the fact that 

maternal mortality and prematurity rates are on the rise, the connections between the two and what we can do on both of those 

issues, and just as Mr. Shimkus is, I am also interested in the 

issue of access to maternal and pediatric care for expectant mothers. I have no doubt that the health care reform bill that extends 

coverage to millions of women across this country is going to be 

able to link them up with the care that they have not had previous 

to today, but I also share Representative Shimkus’s concern about 

the rates that are paid under the Medicaid program and would just 

remind this committee that at one time this Congress had in place 

a system by which the federal government oversaw both the rates 

for OB care and for pediatric care called the Born amendment. 

That amendment was stripped out of the law in 1997, and in the 

House version of the bill, we put back in that federal oversight over 

obstetric rates and pediatric rates, and I would be happy to work 

on a bipartisan basis to try to put back into place some of the lost 

oversight that the federal government has had to make sure that 


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States do the right thing when it comes to obstetric and pediatric 

rates. That issue of access to care is made much, much better by 

the health care bill but can be made even stronger with strong federal oversight over Medicaid rates. 

I am thrilled that the panel is here. I am very eager to hear your 

testimony and again thankful for the opportunity to listen. 

Mr. PALLONE. Thank you. 

The gentlewoman from Tennessee, Mrs. Blackburn. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Mrs. BLACKBURN. Thank you, Mr. Chairman, and welcome to our 

witnesses. I want to thank you for the hearing. 

In my district, Memphis, Tennessee, has one of the highest prematurity and infant mortality rates in the entire Nation, and it is 

a stat that impacts our neighborhoods, our State, and we know the 

impact it has here in our country. Too many mothers around the 

country just do not have, those young mothers don’t have the information that they need and the educational resources that they 

need to keep their babies healthy. And DHS has stated that children of mothers who receive no prenatal care are three times more 

likely to be born at a low birth weight and five times more likely 

to die than those who are born to moms that get that necessary 

prenatal care. 

And earlier this year, the Commercial Appeal, which is the Memphis newspaper, reported that premature birth and low birth 

weight are the biggest causes of those infant deaths in Memphis, 

Tennessee. So we are watching those numbers very closely. And 

since my days in the State Senate, this is an area where we have 

watched this very closely. Indeed, Congressman Cohen and I had 

legislation last year, had a resolution focused on our concern with 

this infant mortality rate. We have some great work that is being 

done in our State to address this. The Porterly Children’s Hospital, 

the March of Dimes, University of Memphis and Memphis city 

schools all have programs, so we have got a partnership that we 

are doing in the public not-for-profit sector to help improve this 

rate. We have also got the UT Health Sciences Center that has a 

grant, a $1.7 million grant that they are working to expand the 

Blues Project, hoping to reduce those rates, and we are focusing 

that on our TennCare eligible moms. 

So welcome. We are pleased to have you with us today. We look 

forward to your testimony, and I look forward to working with you 

on this issue and I yield back, Mr. Chairman. 

Mr. PALLONE. Thank you. 

Next is the gentlewoman from Florida, Ms. Castor. I should mention that Ms. Castor has done quite a bit of work on this prematurity and infant mortality bill and also asked that we have a 

hearing on this subject. 

OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF FLORIDA 

Ms. CASTOR. Well, thank you, Chairman Pallone, very much for 

today’s hearing so we can address infant prematurity and mortality 


tjames on DSK6SPTVN1PROD with HEARING
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and some of my specific concerns about the rising rates of elective 

preterm Cesarean deliveries in the United States, and thank you 

for inviting Dr. Charles Mahan from the University of South Florida, the founder of the Lawton and Rhea Chiles Center for Healthy 

Mothers and Babies. I am honored that he is here today. I would 

also like to extend a special welcome to Dr. Fleischman, everyone 

at the March of Dimes and from the American College of Obstetricians and Gynecologists. 

The overriding message for pregnant mothers and families and 

health providers in the United States has got to be taking babies 

fully to term, to that 39 weeks, 40 weeks unless there is an intervening medical reason. Researchers at the National Center for 

Health Statistics just reported this week that the high rate of premature births is the primary reason that the United States has a 

higher infant mortality rate than other industrialized nations. 

Preterm births are linked to neurodevelopmental disorders and developmental delays. Let us face it, brain development is the key to 

success for babies, when they are young and even into their adult 

years. 

Many premature babies grow up healthy but sadly many do not. 

Some need lifelong constant care and have health problems 

throughout their lives. Although the National Center reported this 

week that preterm births have slightly declined in the United 

States, the rates are still way too high and the rates of preterm 

and low birth weight babies in my home State of Florida are much 

higher and of great concern. Even with all the great advances in 

science, technology, medicine, too many babies are born prematurely and there are disturbing racial disparities we must address. Nationally, the preterm birth rate is 12.3 percent. In my 

home State of Florida, it is nearly 14 percent. The March of Dimes 

gave Florida an F grade on its 2009 premature birth report card, 

so I am committed to working with you to bring that grade up. 

And the Cesarean rate has risen across the country to 32 percent 

of all births as of 2008, and one factor in preterm births may be 

this rising rate of elective C-sections. In Florida, the C-section rate 

is even higher, accounting for roughly 38 percent of all childbirths, 

and they think that in Dade County, Miami, we are approaching 

50 percent now where the World Health Organization said it really 

should be half of that. Elective C-sections prior to 39 weeks really 

put babies at risk, so we need to understand these troubling numbers. The data displaying the rise in C-sections is clear and speculation about the potential overuse of these surgeries is strong. The 

New York Times has featured several articles over the past 6 to 7 

months reporting that late preterm births are the fasting growing 

subgroup of premature births. Cesareans have become the most 

common surgery in American hospitals, and ACOG has recognized 

that the surgery is overused, and the March of Dimes reports that 

C-sections accounted for 92 percent of all preterm births in the 

United States from 1996 to 2004. 

So I would really like to hear from our witnesses about this. I 

think we need more data and research, so I am looking forward to 

your testimony and the input of my colleagues moving forward. 

Thank you. 

Mr. PALLONE. Thank you. 


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The gentlewoman from the Virgin Islands, Ms. Christensen. 

Mrs. CHRISTENSEN. Thank you, Mr. Chair. In the interest of 

time, I am going to submit my statement for the record. 

[The information was unavailable at the time of printing.] 

Mr. PALLONE. And Mr. Braley, the gentleman from Iowa. 

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF IOWA 

Mr. BRALEY. Thank you, Mr. Chairman, for holding this hearing 

on premature and infant mortality. It is important that we examine the many risk factors and variables that relate to these tragedies. 

In Iowa, five mothers who each lost a daughter to stillbirth or 

infant death got together in 2003 and founded Healthy Birthday, 

a nonprofit organization dedicated to preventing stillbirths and infant deaths through education, advocacy and parent support. This 

group of friends including State Representative Janet Peterson 

launched the Count the Kicks campaign in June of 2009, which is 

a public health and awareness effort to improve pregnancy outcomes. This campaign is supported by the March of Dimes Iowa 

chapter and seeks to reduce the number of preventable stillbirths 

by teaching expectant parents how to self-monitor their babies’ 

movements and about the importance of tracking daily movements 

during the third trimester of pregnancy. Less than a year after the 

campaign’s launch, 55 percent of OB/GYN clinics in Iowa and 56 

percent of the birthing hospitals had begun using the program. Research has shown that this type of education and awareness is very 

effective. 

A 2009 study conducted in Norway reported an overall decrease 

in stillbirth rate by one-third when patients were educated on monitoring fetal movements. If the United States achieved the same 

level of success, we could save more than 8,000 babies every year. 

With one out of every 150 pregnancies ending in stillbirth in the 

United States, it is hard to understand why this issue hasn’t gotten 

more attention, but I believe that expanded awareness and education should be an integral part of efforts to reduce stillbirths. 

I commend Chairman Pallone for introducing the Stillbirth and 

SUID Prevention, Education and Awareness Act. This bill will improve the health of children, enhance public health activities related to stillbirth and reduce the occurrence of infant death. I am 

proud to be a cosponsor of this bill and I encourage other members 

of the committee to support the bill, and I yield back the balance 

of my time. 

Mr. PALLONE. Thank you, and I think that concludes our opening 

statements by the members of the subcommittee, so we will turn 

to our witnesses. I want to welcome you. Let me introduce our first 

panel. On my left is Dr. William Callaghan, who is the senior scientist for Maternal and Infant Health Branch, Division of Reproductive Health, the National Centers for Chronic Disease Prevention and Health Promotion of the Centers for Disease Control and 

Prevention. And then we have Dr. Catherine Spong, who is the 

branch chief for the National Institute of Child Health and Human 

Development of the National Institutes of Health. The drill is 5- 

minute opening statements, and they become part of the record and 


tjames on DSK6SPTVN1PROD with HEARING
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then we may—well, you actually on your own discretion if you like 

can submit additional statements in writing afterwards, but if you 

would start, Dr. Callaghan. We appreciate your being here. 

STATEMENTS OF WILLIAM CALLAGHAN, MD, MPH, SENIOR 

SCIENTIST, MATERNAL AND INFANT HEALTH BRANCH, DIVISION OF REPRODUCTIVE HEALTH, NATIONAL CENTER FOR 

CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION, 

CENTERS FOR DISEASE CONTROL AND PREVENTION; AND 

CATHERINE SPONG, MD, BRANCH CHIEF, NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT, NATIONAL INSTITUTES OF HEALTH 

STATEMENT OF WILLIAM CALLAGHAN 

Dr. CALLAGHAN. Mr. Chairman, Mr. Shimkus and distinguished 

members of the subcommittee, thank you for the opportunity to 

participate in this hearing on preterm birth and infant mortality. 

I am Dr. William Callaghan, acting chief, Maternal and Infant 

Health Branch in the Division of Reproductive Health, the Centers 

for Disease Control and Prevention. I am also board certified in obstetrics and gynecology. Prior to making the transition to public 

health in 2001, I spent 14 years in private practice caring for thousands of women during their pregnancies. Today I will briefly outline the burden of disease in the United States due to preterm 

birth and summarize our current and continuing surveillance and 

research activities. 

Preterm birth is defined as being born at less than 37 weeks, 

that is, at least 3 weeks before the predicted due date for the pregnancy. Today, more than half a million babies are born preterm 

each year in the United States. Although a CDC report released 

yesterday shows a very welcome and small decline in the preterm 

birth rate for 2007 and 2008 down to 12.3 percent, levels still remain higher than at any point in the 1980s and 1990s. Most of the 

increase prior to this recent decline was among late preterm births, 

and those are births from 34 to 36 weeks of gestation. 

Preterm birth is an important risk for infant mortality. More 

than one-third of infant deaths can be directly attributed to 

preterm birth. Preterm birth and infant mortality are particularly 

critical issues in the African American community. African American women are one and a half times more likely to deliver a 

preterm infant compared to white women, and the infant mortality 

rate for black infants is more than twice that of white infants. We 

also need to think beyond infant mortality when we discuss prematurity. Preterm birth is the leading cause of disability in children. Moreover, in 2005 it was estimated the costs associated with 

preterm birth were $26.2 billion. 

At CDC, our work addresses preterm delivery through three 

basic mechanisms: surveillance, research and building public 

health capacity. Surveillance is the core of CDC’s work. We monitor 

how many infants are born prematurely, analyze trends and define 

risk factors. There are several important surveillance systems that 

we use. The first is through collection of birth certificates and 

death certificates by the National Center for Health Statistics. The 

national statistics for prematurity rates are compiled from informaVerDate Mar 15 2010 02:39 Feb 16, 2013 Jkt 076576 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 E:\HR\OC\A576.XXX A576

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tion on birth certificates. When birth certificate information is 

linked to information on death certificates, we are able to look at 

the causes of death for those babies who died during their first 

year of life. 

CDC’s second largest surveillance system on maternal and infant 

health is called PRAMS, the pregnancy risk assessment monitoring 

system. PRAMS is an ongoing state-specific surveillance system designed to identify and monitor maternal behaviors and experiences 

before, during and after pregnancy among women who had live 

births. PRAMS has served to expand the information capacity of 37 

States and New York City and this unique surveillance system is 

now representative of approximately 75 percent of all births in the 

United States. CDC also provides resources to assist States in conducting surveillance of major birth defects, which are important 

causes of infant mortality. 

In terms of research, we are working with partners to try to understand some of the biology among women who delivered preterm. 

These studies focus on the interactions among genes, other biologic 

markers, race and ethnicity, and social and economic exposures for 

women. We really don’t know a lot about why late preterm births 

increased and drove the overall preterm birth rate during the last 

several decades. We are currently involved in a study to review 

hospital medical records in order to discover why and how late 

preterm births occur. In the area of capacity building, CDC has 23 

federal staff assigned to State health departments providing technical support for epidemiological research, public health surveillance and State-based programs. 

As we move forward, we will be investigating how the quality of 

surveillance information can be improved and how we can use it 

to inform programs and public health practice. A society measures 

what it values, and we will strive to improve the core public health 

function of surveillance. As new ideas emerge about the reasons for 

and predictors of preterm birth and about possible prevention 

interventions, we will continue to synthesize evidence and attempt 

to fill in knowledge gaps through research. We will continue to 

press forward with our work in the area of understanding late 

preterm birth as this group continues to comprise the largest proportion of preterm births. As we learn more about causes and prevention, we anticipate the result will be more healthy babies and 

healthy families. 

Thank you for the opportunity to speak today, and I would be 

happy to answer questions. 

[The prepared statement of Dr. Callaghan follows:] 


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Testimony before the 

Subcommittee on Health 

Committee on Energy and Commerce 

United States House of Representatives 

Prematurity and Infant Mortality: What Happens 

When Babies Are Born Too Early?" 

Statement of 

William M. Callaghan, MD, MPH 

Acting Chief, Maternal and Infant Health Branch 

Division of Reproductive Health 

National Center for Chronic Disease Prevention and Health 

Promotion 

Centers for Disease Control and Prevention 

U.S. Department of Health and Human Services 

For Release on Delivery 

Expected at 2:00 p.rn 

Wednesday, May 12,2010 
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Introduction 

Mr. Chairman, Mr. Shimkus, and distinguished members of the Subcommittee, thank you 

for the opportunity to participate in this hearing. I am Dr. William Callaghan, Acting 

Chief ofthe Maternal and Infant Health Branch in the Division of Reproductive Health, 

Centers for Disease Control and Prevention (CDC), an agency of the Department of 

Health and Human Services (HHS). I am also board certified in obstetrics and 

gynecology and general preventive medicine. Prior to making the transition to public 

health in 2001, I spent 14 years caring for thousands of women during their pregnancies. 

I am pleased to be here today to participate in discussions of the challenges around the 

issues of preterm birth and infant mortality. It is difficult to speak about infant mortality 

without also speaking about preterm birth. However, as I hope to make clear, preterm 

birth carries risks over and above the risk of infant death and hence, it is one of the most 

important health issues facing women, children, and families in America today. I will 

briefly outline the burden of disease in the nation due to preterm birth and summarize 

current prevention and research activities and challenges. I will close with outlining 

plans for continuing activities as we work together to decrease the burden of preterm 

birth and infant mortality. 

Background 

Preterm birth is defined as being born at less than 37 weeks gestation, that is, at least 

three weeks before the predicted due date for the pregnancy. Throughout the 1990s and 

the early years of the 21 st century, preterm births have steadily increased from just over 9 

percent of all births in the early 1980s peaking at nearly 13 percent in 2006. Now, more 

than a half a million babies are born preterm each year in the United States. I Healthy 

People, a science-based, 1 O-year set of national objectives for promoting health and 

preventing disease, includes an objective to reduce pre-term births. The Healthy People 

2010 Midcourse Review found that pre-term births between 32-36 weeks of gestation and 

less than 37 weeks of gestation moved away from their target improvement goals. The 

rate for pre-term births at less than 32 weeks of gestation did not change by the time of 

the Midcourse Review. The objective to reduce pre-term births will also be included in 

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Healthy People 2020 which will be launched in Fall 2010. Although a recent CDC report 

shows a welcome small decline in the pretenn birth rate for 2007 and 2008, levels remain 

higher than at any point in the 1980s and 1990s. Most of this increase has been among 

late pretenn births (34 - 36 weeks).2 Many factors have likely contributed to the rise in 

the late preterm birth rate. One factor may be that the way pregnancy is managed has 

changed over this period, that is, there may be a lower threshold to induce labor or deliver 

by cesarean section at 34 - 36 weeks of gestation in recent times. While such 

intervention is often necessary for the health of both the mother and her infant, little is 

known about how case-by-case decisions regarding interventions are made. 

Pretenn birth is an important risk for mortality and short- and long-term disease and 

disability. Two-thirds of the approximately 28,000 infants who die each year are born 

preterm, although we cannot always say that being preterm was the direct cause of death. 

However, even when we use conservative assumptions from death certificate infonnation, 

more than one-third ofinfant deaths can be directly attributed to preterm birth; more 

infants die as a direct result of being born too early than of any other cause.3 This 

preterm-associated risk is strongly related to how far into pregnancy the birth occurs. 

Those babies born at the early limits of living outside their mothers' wombs have a poor 

chance of surviving the first year, and these smallest and earliest babies, while accounting 

for only two percent of all births, bear the greatest mortality risk.4 Little progress has 

been made in reducing infant mortality in recent years and little progress has been made 

in reducing the fraction of births at the earliest gestations (less than 32 weeks gestation). 

Moreover, approximately eight percent of pretenn births or about 40,000 pretenn births 

also have a major birth defect.s Until we can reduce the occurrence ofpretenn birth and 

major birth defects, it will be very difficult to see any dramatic reduction in the U.S. 

infilllt mortality rate. 

The issue of pre term birth as it relates to infant mortality is at crisis proportions for 

African Americans. African-American women are one and one-halftimes more likely to 

deliver a pretenn infant compared to white women; they are more than twice as likely to 

deliver a very preterm infant (less than 32 weeks gestation) compared to white 

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women. 1 The infant mortality rate for black infants is more than twice that of white 

infants,2 and the infant mortality rate due to major birth defects is approximately 40 

percent higher in African Americans than in non-Hispanic white women.6 

The death of an infant is a tragedy. Deaths are relatively easy to measure. Hence, we 

put a lot of emphasis on the outcome of infant mortality. However, while most infant 

deaths have at least an association with being born preterm, most preterm infants do not 

die. One reason for this is the great strides that have been made in the intensive care of 

these smallest of newborns. Another reason, not wholly unrelated, is that most preterm 

infants are born at the high end of the preterm gestational age range, i.e., late preterm. 

Although these infants have a higher infant mortality rate than term infants, deaths during 

the first year of life are much lower than those born earlier in pregnancy. Hence, we need 

to think beyond infant mortality when we discuss prematurity as a public health problem. 

Preterm birth is a leading cause of neurological disability, such as cerebral palsy and 

intellectual disabilities, in children. It can also result in blindness and chronic lung 

problems.7 We are only now beginning to understand the lifelong impact that being born 

too small and too early has on the individual and their families. Premature births extract 

a huge financial toll on our health care resources - in 2005 it was estimated that medical 

care, early intervention services, special education services and lost productivity 

associated with preterm birth cost $26.2 billion? There is also an emotional toll. Taken 

together, it is clear that preterm delivery is a public health priority. 

During my years as a practicing obstetrician, all too often my patients and I were faced 

with the unexpected situation of pre term delivery. Although women who have preexisting medical conditions such as hypertension or who have pregnancies with impaired 

fetal growth are at risk for early delivery because of concerns for the health of the mother 

or fetus, it is difficult to predict the spontaneous occurrence of pre term labor. Women 

who had a preterm birth in the past are a notable exception. Weekly injections of 17-

hydroxyprogesterone caproate (l7-P) have been shown to reduce the risk of preterm birth 

among women who had a preterm birth in the past, 8 and this treatment is important in 

this subgroup of women. The estimated reduction in the preterm birth rate from universal 

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usage of this medication in the United States has been estimated to be about two percent,' 

and it is important that this treatment be used for women who had a prior pretenm birth. 

However treatment alone with 17-P will not eliminate pretenm births. Hence, we are left 

with unacceptably high rates of death and disability due to preterm birth. It is clear that 

solutions to the challenge of pretenm delivery must come through better understanding of 

causes and applying that understanding to develop effective interventions. 

Current Research and Challenges 

Pretenm birth is not a new challenge and it has not gone unaddressed. We must continue 

working toward the goal of predicting preterm birth and developing rational interventions 

to prevent it. At CDC, our work addresses pretenm delivery by monitoring trends, 

sponsoring and conducting research and sponsoring programs, all of which attempt to 

address the social and biomedical factors that affect pretenm risk. We achieve this 

through three basic mechanisms: surveillance, research, and capacity-building of states 

and communities. 

Surveillance: 

Surveillance is the core of CDC's work; we monitor how many infants are born 

prematurely, analyze trends, define risk factors, and target prevention programs, based on 

these data and analyses. Surveillance is our early warning system. It tells us ifthere is a 

new emerging health threat and if our programs are effective. There are several 

important surveillance systems that we use. 

The first is through collection of birth certificates and death certificates by CDC's 

National Center for Health Statistics (NCHS). For prematurity, this is the backbone of 

health surveillance - all of the national statistics for prematurity rates are compiled from 

infonmation on the birth certificate. We are also able to use birth certificate infonmation 

to evaluate factors such as mother's education, tobacco use, race, and the infant's 

birthweight. It allows us to follow trends, risk factors, and identify variations in rates of 

preterm births at the state and county levels. When birth certificate infonmation is linked 

to infonmation on death certificates, we are able to look at causes of death for those 

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babies who died during their first year of life. U sing data from this linked file, we were 

able to demonstrate the strong relationship between preterm birth and infant mortality. 

Each year, NCHS reports in detail on preterm birth rates across the country and on 

"preterm-related" infant mortality, and released new data on this earlier this week. 

CDC has on-going projects to evaluate and improve the quality of the data from these 

new systems, but support to develop effective training for hospital personnel to 

thoroughly and accurately report gestational age and other vital statistics information is 

needed. CDC has also conceived a project to develop standards and pilot studies for the 

collection of selected vital records data such as gestational age via the use of the new 

electronic health records; we expect that this new approach will greatly enhance the 

timeliness and quality of gestational age data. The FY 2011 Budget requests additional 

resources to modernize vital records received from States and other jurisdictions to 

increase their timeliness and accuracy by implementing electronic birth registration, and 

phasing in electronic death registration through a 50-50 match. This will allow all states 

to have implemented EBRs or be in the process of developing by FY 2011. CDC's 

second large surveillance system on maternal and infant health is called PRAMS - the 

Pregnancy Risk Assessment Monitoring System. PRAMS is an ongoing, state-specific, 

population-based surveillance system designed to identiJY and monitor selected maternal 

behaviors and experiences before, during, and after pregnancy. Through this system, we 

have been able to better understand issues such as prenatal care, folic acid to prevent birth 

defects, obesity, pregnancy weight gain, stressful life events, and physical abuse. For 

example, an analysis of PRAMS data showed that very low weight gain during pregnancy 

increases the risk of pre term birth, regardless of prep regnancy body mass index.tO 

PRAMS has served to expand the capacity of37 states and New York City to define and 

address their health needs, and this unique surveillance system is now representative of 

approximately 75 percent of all births in the United States. It has provided vital 

information to program managers and decision-makers for development of policy and 

programs in maternal and infant health. For example, information from PRAMS is used 

in states as part of the criteria for distribution of Title V Maternal and Child Health block 

grants. 

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In addition, CDC provides resources to assist states in conducting surveillance of major 

birth defects, including the collection of data on the gestational age at delivery of infants 

with major birth defects. Data from the surveillance systems have allowed CDC to 

develop national prevalence estimates, study the association between preterm birth and 

major birth defects, and identify risk factors for birth defects including smoking in early 

pregnancy and pre-pregnancy obesity. 

In addition to these large surveillance systems, CDC also uses more focused surveillance 

to address specific health issues. Under Congressional mandate, CDC collects and 

analyzes data from all clinics that use infertility treatment called ART or Assisted 

Reproductive Technology. We have identified how this technology is associated with 

elevated low birth weight and prematurity, but there is still much that we could learn 

through expanding this work. For example, linking ART surveillance data with birth and 

death files in states will provide a population-based database to examine maternal and 

infant health outcomes associated with this technology.11 Although recent research has 

indicated that ART is not the primary driving force for preterm delivery in the U.S., it is 

important to continue to monitor its impact on preterm delivery. For example, we know 

that twins, triplets and higher order multiple births are at greater risk of delivering 

preterm, and ART surveillance data helps us understand how ART procedures contribute 

to increases in mUltiple births. 

Research: 

A complex array off actors interferes with healthy pregnancy outcomes and racial 

disparities. Decades of research at NIH suggests that treatment of infections may not be 

successful in preventing preterm delivery. Perhaps the body's inflammatory response to 

infection, and not the infection itself, is damaging to the pregnancy. There are damaging 

by-products of inflammation that spread throughout the body and result in increased risk 

of premature birth. We know that tobacco use and psychological stress from living in 

poor neighborhoods create the same damaging chemicals in the body as infection. The 

same inflammatory factors have been identified in heart disease.7 We are currently 

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working with partners to try to understand some of the biology associated with the 

inflammatory response among women who delivered early preterm. One focus of these 

investigations is to understand how variations in genes that govern the human 

inflammatory-response might predispose to preterm birth, and how these variations 

interact with maternal race and ethnicity as well as social and economic exposures for the 

woman. Such lines of inquiry will likely generate more questions than answers, but they 

are questions that must be pursued if we are to make progress. 

We know little about why late preterm births, births occurring between 34 and 36 weeks 

gestation, increased and drove the overall preterm birth rate during the last several 

decades. We are currently involved in a small study in metropolitan Atlanta to identify 

late preterrn births and review the medical records of these women and infants in order to 

discover if it is feasible to expect that the answer as to why and how the birth occurred 

can be found in the medical records. 

Public Health Capacity: 

In the area of capacity-building, CDC has 23 federal staff assigned to state health 

departments, providing technical support for epidemiological research, public health 

surveillance, state-based programs, and one of the Indian Health Service's epidemiology 

centers. 

Despite the complexities of preventing preterm delivery, there are ways we build public 

health capacity and act now. Tobacco use, for example, remains a significant preventable 

cause oflow birth weight, preterrn birth and of some major birth defects. CDC has 

responded by working with state health departments to assist with smoking cessation 

programs during pregnancy. 

The Path Forward 

We will continue to work with federal, state and academic partners to address the public 

health challenges ofpreterrn birth and infant mortality. The information in vital statistics 

is the foundation for understanding where we are and measuring progress and we will be 

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investigating how the quality of that information can be improved and used to inform 

programs and public health practice. Along these lines, we will continue to enhance the 

capacity of states to use their vital statistics and PRAMS data for action. A society 

measures what it values, and we will strive to improve the core public health function of 

surveillance. 

As new ideas emerge about the reasons for preterm birth, potential predictors and 

possible prevention interventions, we will continue to synthesize evidence and attempt to 

fill in knowledge gaps. Moreover, we will use our ability to convene partners in efforts 

to bring together the most recent thinking so that research and practice might be 

thoughtful and evidence-based. Although progress in improving preterm birth and infant 

mortality rates might not be as rapid as we would all hope, and racial disparities continue, 

bringing the best minds together to address these challenges is an important step forward. 

We will continue to press forward with our work in the area of understanding late 

preterm birth, as this group continues comprise the largest proportion of preterm births. 

It is likely that this will involve new techniques such as qualitative research involving key 

informant interviews and focus groups to better understand how decisions are made 

regarding when and how delivery should occur. 

Conclusion 

Prevention of pre term birth is an important public health priority. Back in 1917, Dr. 

Grace Meigs who was in charge of the hygiene division for the Children's Bureau was 

tasked with investigating the reasons for high infant mortality rates. The findings of her 

investigation led her to conclude that the problem of infant mortality is inextricably tied 

to the health of women. We can say the same today, nearly a century later. As we learn 

more about causes and prevention, we hope the result will be more healthy babies and 

healthy families. 

Thank you for the opportunity to speak to you about preterm birth. At this time, I would 

be happy to answer your questions. 

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References 

I. Martin lA, Hamilton BE, Sutton PD, Ventura Sl, et al. Births: Final data for 2006. 

National vital statistics reports; vol 57 no 7. Hyattsville, MD: National Center for 

Health Statistics. 2009. 

2. Hamilton BE, Martin lA, Ventura S1. Births: Preliminary data for 2008. 

National vital statistics reports; vol 58 no 16. Hyattsville, MD: National Center 

for Health Statistics. 20 I O. 

3. Callaghan WM, MacDorman MF, Rasmussen SA, Qin C, Lackritz E. The 

contribution of pre term birth to infant mortality rates in the United States. 

Pediatrics 2006;118: 1566-1573. 

4. Mathews TJ, MacDorman MF. Infant mortality statistics from the 2006 period 

linked birth/infant death data set. National vital statistics reports; vol 58 no 17. 

Hyattsville, MD: National Center for Health Statistics. 2010. 

5. Honein MA, Kirby RS, Meyer RE, Xing 1, Skcrrette NI, Yuskiv N, et al. TIle 

association between major birth defects and preterm birth. Mat Child health 1. 

2009; 13:164-175. 

6. Heron M. Deaths: Leading causes for 2006. National vital statistics reports; vol 

58 no 14. Hyattsville, MD: National Center for Health Statistics. 2010. 

7. Behrman RE, Butler AS. (Eds) (2007) Preterm Birth. Causes, Consequences and 

Prevention. Washington, DC National Academies Press. 

8. Meis Pl, KlebanoffM, Thorn E, Dombrowski MP, Sibai B, Moawad AH, et al. 

Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone 

caproate. N Engl 1 Med 2003;348-2379-2385. 

9. Petrini JR, Callaghan WM, KlebanoffM, Green NS, Lackritz EM, Howse JL, et 

al. Estimated effect of 17 alpha-hydroxyprogesterone caproate on preterm birth in 

the United States. Obstet Gynecol 2005; 105:267-272. 

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10. Dietz PM, Callaghan WM, Cogswell ME, Morrow B, Ferre C, Schieve LA. 

Combined effects of prep regnancy body mass index and weight gain during 

pregnancy on the risk ofpreterrn delivery. Epidemiology 2006;17:170-177. 

11. Zhang Z, Macaluso MM, Cohen B, Schieve L, Nannini A, Chen M. Accuracy of 

assisted reproductive technology information on the Massachusetts birth 

certificate, 1997-2000. FertU Steril [Epub ahead of print]. 

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32 

Mr. PALLONE. Thank you, Dr. Callaghan. 

Dr. Spong. 

STATEMENT OF CATHERINE SPONG 

Dr. SPONG. On behalf of the Eunice Kennedy Shriver National 

Institute of Child Health and Human Development at the National 

Institutes of Health, I appreciate the opportunity to provide the 

committee with information about our research programs on 

preterm birth and infant mortality. 

I am Dr. Catherine Spong, chief of the Pregnancy and 

Perinatology Branch at the NICHD. The NICHD mission is to ensure that every person is born healthy and wanted, that women 

suffer no adverse harmful effects from reproductive processes and 

that all children have the chance to achieve their full potential for 

healthy and productive lives free from disease or disability. As 

such, research on prematurity and its health outcomes falls squarely within the Institute’s mission. 

As we have heard from your opening statements and as Dr. 

Callaghan eloquently stated, preterm birth is a major public health 

problem. In 2001, preterm birth became the leading cause of death 

among newborns, and those who survive preterm birth account for 

one in five children with mental retardation, one of three children 

with vision impairment and almost half of all children with cerebral palsy. Late preterm infants appear to be at higher risk for 

sudden infant death syndrome and have higher rates of neurological and developmental morbidities during childhood. In adulthood, children born at low birth weight have an increased risk for 

cardiovascular disease such as heart attacks, strokes and hypertension and an increased risk for diabetes. 

The NIH is committed to understanding the causes and to reducing the incidence of preterm birth, low birth weight and infant 

mortality and their consequences. The NICHD was the lead federal 

agency in planning and coordinating the surgeon general’s conference on prematurity prevention held in June of 2008. As I will 

describe, NICHD preterm research efforts address these recommendations and range from basic work on the mechanisms of 

labor, genetics and proteomics to research regarding specific questions encountered in clinical practice and the long-term implications on the infant, mother and family. 

While the NICHD supports the bulk of NIH research in this 

area, other institutes and centers also contribute to the overall 

NIH funding for infant mortality, low birth weight and prematurity 

research projects. This totaled $278 million in fiscal year 2009 including ARRA funds, the last year for which we have complete 

data. 

One of the most successful approaches for research related to 

prematurity are the NICHE research networks, which allow physicians and scientists across the country to coordinate their work and 

share data. The Maternal Fetal Medicine Units Network, composed 

of 14 sites across the country, conducts clinical studies to improve 

maternal, fetal and neonatal health. This network has a remarkable track record of conducting high-priority clinical trials with its 

findings incorporated into practice. The Neonatal Research NetVerDate Mar 15 2010 02:39 Feb 16, 2013 Jkt 076576 PO 00000 Frm 00038 Fmt 6633 Sfmt 6633 E:\HR\OC\A576.XXX A576

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33 

work focuses on babies in neonatal intensive care units to improve 

their health and outcome. 

The NICHD recently has funded a study on women in their first 

pregnancy, the Nulliparous Pregnancy Outcome Study. The best 

predictor of preterm birth, pregnancy outcome, is not available for 

these women yet they account for 40 percent of all deliveries each 

year. The aim of this large multicenter study is to identify markers 

early in pregnancy that will identify women at the highest risk for 

preterm birth, preeclampsia and stillbirth with the goal to ultimately develop interventions and therapies. 

To understand the biologic mechanisms underlying spontaneous 

preterm births, the NICHD is supporting a wide range of research 

including intrauterine infection, bleeding and psychosocial stress. 

Another major emphasis is on preeclampsia as it is the primary 

reason for medically indicated preterm births. Research supported 

by NICHD has shown that this disease is associated with an abnormal development of the placenta. NICHD-supported research identified and highlighted the significant complications associated with 

late preterm births, those babies born between 34 and 37 weeks, 

that account for 70 percent of all preterm births, these supported 

practice guidelines affect changes in practice. 

One aspect of research is to identify markers or predictors of 

preterm birth. A short cervical length is a predictive marker and 

was identified through NICHD research. In a blinded, multicenter 

observational study of women with a prior preterm birth, shortened 

cervical length in mid-pregnancy can predict early spontaneous 

preterm birth. This has led to screening for cervical length in 

women who are at risk for preterm delivery. 

Ideally, the best outcome would be to prevent preterm birth in 

the first place. A major advance in prevention was made by the 

NICHD’s Maternal Fetal Medicine Network studying women who 

have had a previous preterm delivery and therefore were at risk for 

a recurrent preterm birth. This trial compared progesterone to placebo, and progesterone treatment lowered the risk of preterm birth 

by one-third, the first successful preventative therapy to reduce the 

risk of recurrent preterm birth and improve neonatal outcomes. 

The impact of this treatment was evaluated in a 2005 study, which 

estimated that 10,000 preterm births could be prevented annually 

if all eligible pregnant women received progesterone. The American 

College of Obstetricians and Gynecologists has recommended the 

use of progesterone to prevent preterm birth for women with a 

prior spontaneous preterm birth. 

In addition to studying preventative therapies, the MFMU Network studies interventions during pregnancy to prevent complications in preterm infants. Recently, the network identified a therapy, magnesium sulfate, or Epsom salts, which when administered 

to women who are at risk of delivering preterm, reduces the risk 

of cerebral palsy in surviving preterm infants by 45 percent. 

The NICHD also supports research on how to manage and care 

for preterm infants. One example is nitric oxide, a compound that 

is used to treat infants with severe breathing problems, but the 

safety and efficacy for premature infants has had mixed results. To 

better understand the potential risks and benefits of inhaled nitric 

oxide therapy, the NIH will convene a consensus development conVerDate Mar 15 2010 02:39 Feb 16, 2013 Jkt 076576 PO 00000 Frm 00039 Fmt 6633 Sfmt 6633 E:\HR\OC\A576.XXX A576

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34 

ference in October of this year to assess the available scientific evidence and form conclusions about its clinical use in preterm infants. 

Both preterm infants and infant mortality have dramatic health 

disparities with higher overall rates in African American women. 

NICHD-supported researchers are attempting to identify the factors to explain these disparities, and in August of this year the 

NICHD will hold a scientific workshop focused on disparities in infant mortality, stillbirth and preterm birth. 

Given the implications of preterm birth on long-term health and 

disease of the child and family and affecting over half a million 

pregnancies each year, preterm birth truly is a public health priority. Were we able to prevent preterm births, not only would infant mortality improve, we would actually improve the health of 

the Nation with less heart disease and diabetes in the children and 

healthier mothers and families. This is our goal. 

Again, thanks to the committee for your time and interest, and 

I am pleased to answer any questions that you may have. 

[The prepared statement of Dr. Spong follows:] 


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Testimony before the 

Subcommittee on Health 

Committee on Energy and Commerce 

United States House of Representatives 

Prematurity and Infant Mortality: What 

Happens When Babies Are Born Too 

Early? 

Statement of 

Catherine Y. Spong, M.D. 

Chief, Pregnancy and Perinatology Branch 

Eunice Kennedy Shriver National Institute of Child 

Health and Human Development 

National Institutes of Health 

U.S. Department of Health and Human Services 

For Release on Delivery 

Expected at 2:00 p.m 

Wednesday, May 12,2010 
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On behalf of the Eunice Kennedy Shriver National Institute of Child Health and Human 

Development (NICHD) at the National Institutes of Health, I appreciate the opportunity to 

provide the Committee with information about our research program on preteI'm birth and related 

issues. I am Dr. Catherine Spong, Chief of the Pregnancy and Perinatology Branch at the 

NICHD. The mission of the NICHD is to ensure that every person is born healthy and wanted, 

that women suffer no harmful effects from reproductive processes, and that all children have the 

chance to achieve their full potential for healthy and productive lives, free from disease or 

disability, and to ensure the health, productivity, independence and well-being of all people 

through optimal rehabilitation. As such, research on prematurity and its health outcomes falls 

squarely within the institute's mission. 

Background 

Preterm delivery is a major public health problem. The preterm birth rate in the U.S. is over 12 

percent of all live births, accounting for over half a million premature births each year (I). Over 

the last two decades, preterm birth rates have risen approximately 30 percent. Concomitant with 

the rise in preterm births is a rise in multiple gestations, due in a large part to the increased use of 

assisted reproductive technologies. The number of twin births doubled between 1980 and 2006. 

(1). 

In 200 I, preterm birth is the leading cause of death in newborns who die within the first month. 

(2). It is the leading cause of death among African-American infants and the second leading 

cause of all infant mortality. In those who survive, 8 percent of all preterm births also have a 

major birth defect, and 16 percent of very preterm births (less than 32 weeks gestation) have a 

major birth defect: pretenn birth accounts for one of five children with mental retardation, one 

of three children with vision impairment and almost half of children with cerebral palsy. In 

adulthood, children born at a low birth weight have an increased risk for cardiovascular disease 

such as myocardial infarction, stroke and hypertension, and an increased risk for diabetes, and a 

possible increase in cancer risk (3). For the mother, delivering preterm increases her risk by 

nearly two-fold for a subsequent preteI'm delivery (4). In addition, there is a racial disparity in 

both the baseline and recurrence rates of preteI'm births. Tn 2004, preteI'm births occurred in 11.5 

percent of Caucasian women and 17.9 percent of non-Hispanic black women. With one previous 

preteI'm birth, the recurrence rates of pre term births are 15-20 percent in Caucasian women, and 

26 percent in black women. The additive risk associated with multiple prior preterm hirths is 

especially evident when early preterm births are considered. Women with one prior preterm 

delivery less than 35 weeks have a 16 percent recurrence risk, those with two early preteI'm 

deliveries have a 41 percent risk, and those with three prior preteI'm deliveries have a 67 percent 

risk of subsequent preterm birth before 35 weeks (5). 

Of the over 540,000 preterm births in the United States each year, 70 percent are late preterm 

births (delivering between 34-36 weeks of gestation)(I). These infants account for about 40 

percent of Neonatal Intensive Care Unit (NICU) admissions. Not only has the preterm birth rate 

increased in the U.S. from 9.1 percent (1981) to 12.3 percent (2008), but the rate oflate preterm 

deliveries has also increased from 7.3 percent (1990) to 8.8 percent of all live births (2008). 

Data from 2008 indicate a slight decrease in the overall preterm birth rate, which primarily 
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reflects a decrease in late preterm births to 8.77 percent (I). These infants are at higher risk for 

sepsis, pneumonia, hypoglycemia, temperature instability, hyperbilirubinemia, kernicterus, 

feeding difficulties, white matter damage, seizures, and apnea, and for re-hospitalization after 

initial hospital discharge. Compared to their term counterparts, late preterm infants appear to be 

at a higher risk for Sudden Infant Death Syndrome (SlDS) and have higher rates of neurological 

and developmental morbidities during childhood. 

The NIH is committed to understanding the causes of pre term birth and to reduce the incidence 

of pre term birth, low birth weight and infant mortality and their consequences. The NICHD was 

the lead federal agency in planning and coordinating the Surgeon General's Conference on the 

Prevention of Prematurity, held in June 2008 (6, 7). Federal agencies, nonprofit organizations, 

professional societies, and members of the public whose lives had been affected by preterm birth 

all participated in formulating an agenda to heighten the visibility of pretenn birth and its 

consequences, and to provide guidance on top priority. cross-cutting efforts to speed the 

identification of the causes, risk factors, and treatment of pre term labor and delivery. 

Preterm birth research supported by the NICHD ranges from basic work on genetics and 

genomics to research regarding specific questions encountered in clinical practice, including the 

mechanisms, prediction and prevention of pre term delivery, optimal management of pre term 

labor, optimal management of the preterm neonate and the long-term implications of pre term 

delivery on the infant, mother and family. The NICHD supports this work through the funding 

of investigator-initiated applications, specific solicitations for individual grants and networks, the 

identification of high priority topics, and the identitication and highlighting of gaps through the 

use of conferences and workshops. In addition to funding a wide range of extramural research, 

the NICHD's intramural program includes a branch largely devoted to issues related to 

pregnancy, preterm birth and congenital anomalies. While the NICHD supports the bulk of NIH 

research in this area, other NIH institutes and centers also contribute to the overall NIH spending 

of$278 million, including $32 million in Recovery Act funds, for infant mortality/low birth 

weight/prematurity research projects in FY 2009, the last year for which we have complete data. 

One of the most successful approaches for research related to prematurity is the NICHD's 

research networks, which allow physician scientists across the country to coordinate their work 

and share data. Currently, four networks focus on specific aspects of prematurity and its 

consequences. The first, the Maternal Fetal Medicine Units (MFMU) Network 

(http://www.bsc.gwu.edu/mfinu) conducts clinical studies to improve maternal, fetal and 

neonatal health emphasizing randomized-controlled trials. The aims of the Network are to 

reduce maternal, fetal and infant morbidity related to preterm birth, fetal growth abnormalities 

and maternal complications and to provide the rationale for evidence-based, cost-effective, 

obstetric practice. The MFMU Network is composed of 14 sites across the US and an 

independent data center. This network has a remarkable track record of conducting high priority 

clinical trials, with its findings incorporated into practice through professional societies. Work 

from this network includes the identification of preventative therapies for preterm birth in current 

practice that should be stopped as they have no impact on the preterm birth rate and on therapies 

that improve outcomes for preterm infants. 

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A second network, the Neonatal Research Network (like the MFMU, established in 1986), aims 

to improve the care and outcome of neonates, especially very low birthweight infants. It has led 

to several advances to improve the survival of infants, and additional work is addressing 

complications in the areas of infection, breathing problems, and neurodevelopmental outcomes. 

Currently the NRN is composed of 16 clinical centers and one data center. 

Another network is the Genomic and Proteomic Network for Preterm Birth Research 

(GPNIPBR). Multiple factors may determine an individual woman's risk of pre term birth 

including her genetic makeup and the way(s) that her genes control the expression of substances 

such as proteins, hormones, and infection-fighting agents. To search the myriads of human genes 

and proteins for abnormalities that could help explain preterm birth, the NICHD's Genomic and 

Proteomic Network for Preterm Research (GPNIPBR) was introduced as a five-year initiative in 

2006. Its main objective is to use wide-scale, high-output genomic and proteomic strategies to 

accelerate knowledge in the mechanisms responsible for premature birth. Approaches such as 

genome-wide scans and global serum protein profiling will be used to identifY new biomarkers 

that increase the risk or are predictive of a preterm delivery and to delineate molecular 

mechanisms responsible for a preterm birth. 

The NICHD has recently funded the Nulliparous Pregnancy Outcomes Study: Monitoring 

Mothers-to-Be, which will address another important aspect of preterm birth. Women for whom 

the current pregnancy will lead to their first delivery (nulliparas) comprise about 40 percent of 

the approximately 4.3 million births in the United States each year. Because there is no 

information from previous pregnancy outcomes to guide assignment of risk or mitigating 

interventions, adverse pregnancy outcomes in nulliparas are especially unpredictable. 

Complications during the first pregnancy affect subsequent pregnancies. This Network will 

study the mechanisms and predictors of adverse pregnancy outcomes in nulliparous women. The 

aim of this large, multicenter cohort study is to identifY markers early in pregnancy that will 

identifY women at the highest risk for preterm birth, preeclampsia, fetal growth restriction, and 

stillbirth. Detailed epidemiologic data, intensive clinical research assessments and biologic 

samples will be collected. Recent advances in genomics, proteomics and epigenetics will be 

applied to elucidate the mechanisms ofthe interplay of genetic and environmental tactors. 

Ideally, using the findings from this study, individualized interventions can be developed aimed 

at preventing adverse pregnancy outcomes. Grantees will share data with investigators outside 

the network, to accelerate the pace of prctcm1 birth research. 

Another highly useful method for consolidating currently available scientific data and informing 

practice are the NIH Consensus Development Conferences. In recent years, the NIH has focused 

twice on the role of Cesarean delivery on preterm birthIn 2006, the NIH held the first conference, 

"Cesarean Delivery on Maternal Request," which found that the incidence of cesarean delivery 

without medical or obstetric indication has increased in the U.S. Given the risks of 

complications that rise with each cesarean delivery, the conferees stated that cesarean delivery on 

maternal request should not be recommended for women desiring several children, and should 

not be performed without medical indication prior to 39 weeks gestation in order to maximize 

lung maturity. Thc NIH followed up this earlier conference with another held in March 20 I 0, 

"Vaginal Birth after Cesarean." The panel convened for this recent conference found that, in 

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women who had undergone prior cesarean delivery, while both vaginal birth after cesarean 

delivery and subsequent cesarean delivery have important risks and benefits for both the 

pregnant woman and the fetus, given the available evidence, vaginal birth after cesarean is a 

reasonable option for many pregnant women, The panel emphasized that both the pregnant 

woman and her clinician should engage in a shared decisionmaking process, The conferees' 

statement from the first conference, can be found at: http://consensus.nih.gov/2006/cesarean.htm, 

and the statement from the March, 2010, conference, at http://consensus.nih.gov/2010/vbac.htm. 

Understanding the mechanism 

Approximately fifty percent of pre term births occur spontaneously following the premature onset 

oflabor, 20 percent are medically-induced deliveries due to medical conditions endangering the 

mother and/or fetus, and 30 percent are associated with the preterm premature rupture of fetal 

membranes leading to either a spontaneously or medically- induced delivery. Consequently, the 

cause(s) for a preterm delivery is dependent on its categorical type. 

Research supported by the NICHD has indicated that spontaneous pretenn birth has a number of 

possible causes (8). These include intrauterine infection/inflammation, uterine bleeding, 

excessive uterine stretch, maternal psychosocial stress, and fetal physiological stress. Certain 

causes are more prominent during certain stages of pregnancy. For example, intrauterine 

infection is associated more often with an early (less than 34 weeks) than a late (34-36 weeks) 

spontaneous preterm delivery. The physiological processes underlying these causes are currently 

an area of intense study. 

The main pregnancy complications leading to a medically-induced preterm delivery are 

preeclampsia, fetal distress, and fetal growth restriction. Notably, preeclampsia is a major focus 

of research supported by NICHD since it is the primary reason for a medically-indicated, preterm 

delivery, accounting for approximately 40 percent of all medically-induced preterm births. 

Preeclampsia is a pregnancy-specific, hypertensive disorder and occurs in about four percent of 

all live-birth pregnancies. Researchers supported by the NICHD have shown that this disease is 

associated with abnormal development of the placenta, which results in reduced blood flow 

between the mother and the fetus (9). 

NICHD-funded researchers are exploring the use of drugs to manipulate certain protective 

enzymes to improve placental function. One enzyme being studied is a potent antioxidant 

defense protein called heme oxygenase-l (HO-I), which has emerged in recent years as an 

important mediator of tissue protective and anti-inflammatory actions (10). It has been shown 

that HO-l is crucial for keeping the human uterus in a relaxed state during pregnancy. A reduced 

level of placental HO-l seems to be associated with a higher risk for preeclampsia. Therefore, 

the unique combination of tissue protective and smooth muscle relaxing properties of the enzyme 

HO-I makc it an interesting target for treatment of preeelampsia, and thus, possible prevention of 

many medically-indicated preterm births. 

Research has indieated that preterm premature rupture of the fetal membranes (pPROM) has 

multiple causes. They include chronic inflammation and lor infection, repeated stretching, 

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maternal stress, and trauma. The likelihood of pPROM being the cause for a preterm delivery is 

higher for an early than a late preterm delivery; approximately 21 percent and 8 percent, 

respectively. The most common causes for pPROM, currently under investigation, appear to be 

chronic inflammation and/or infection. 

Prediction of Pre term Birth 

Fetal growth restriction is a risk factor for preterm birth. Labor and fetal growth involves a 

complex interplay of factors and signaling molecules within the maternal, placental, and fetal 

tissues. Recent advances have implicated placental corticotropin-releasing hormone (CRH) as 

one of the primary endocrine mediators of spontaneous labor and, possibly, offetal development. 

NICHD-funded researchers have made substantial progress in a prospective study of women 

with a singleton pregnancy demonstrating that a single measurement ofCRH at 33 weeks of 

pregnancy predicts fetal birth weight and identifies patients at high risk for preterm labor. These 

results, although not final, demonstrate that, in humans, placental CRH directly participates in 

the physiologic processes of parturition and fetal growth and maturation, as evidenced by the 

prospective relationship between elevated CRH levels and increased risk for pretenn birth and 

fetal growth restriction. 

Cervical length seems to be a predictor of spontaneous preterm birth. The NICHD's MFMU 

Network conducted a blinded, multicenter observational study of women with a prior preterm 

birth(ll). The study showed that in high-risk women, shortened cervical length in the midtrimester predicts early, but not later, spontaneous preterm birth. The results of this and other 

related studies of women at high-risk for preterm birth point to an association between cervical 

length and diminished cervical competence. Another NICHD-funded trial evaluated the use of 

cervical cerclage (a stitch around the cervix like a purse string) in high risk women with a short 

cervix and found in a subset that the cerclage significantly prevented preterm birth (12). 

Home Uterine Activity Monitors (HUAM) have been widely prescribed for patients in the 

anticipation that detecting those patients who were having frequent uterine contractions would 

identiry those patients who would deliver preterm. However, a team of researchers supported by 

the NICHO's MFMU Network found that portable monitors that detect contractions of the uterus 

do not appear to be useful for identirying women likely to deliver preterm(13). This work has 

demonstrated the failure of this new technology to attain a more precise diagnosis, and has 

stopped its ineffective and expensive use from spreading. 

The NICHD also recently used part of its American Recovery and Reinvestment Act funding to 

support a grant to test a new, non-invasive technology device to study the physiological 

mechanism of uterine contractions through magnetic recordings. Insights from these recordings 

may provide innovative approaches toward suppression of pre term labor and induction oflabor. 

Prevention of Pre term Birth 

A major advance in prevention of preterm birth was made in 2003 by a team of researchers 

supported by the NICHD's MFMU Network, who studied women who had had a previous 

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preterm delivery and therefore were considered at high risk for recurrent preterm delivery. This 

clinical trial compared weekly treatment by injection of a progesterone (17 alphahydroxyprogesterone caproate) with placebo in women at high risk for preterm birth(l4). These 

treatments lowered the risk of a second preterm birth by one-third, the first successful treatment 

demonstrated to reduce the risk of recurrent preterm delivery and improve neonatal outcomes in. 

a subset of high-risk women. The impact of this treatment was evaluated in a study published in 

2005, which estimated that 10,000 preterm births could have been prevented annually ifall 

eligible pregnant women had received it (a reduction of about two percent)(15). This 

preventative therapy has been translated into practice; the American College of Obstetricians and 

Gynecologists has recommended the use of progesterone to prevent preterrn birth for women 

with prior spontaneous preterrn birth(16). Since that time, the MFMU Network has evaluated 

other high risk groups, such as women with multiple gestations (twins and triplets), but thus far 

has found that progesterone is not beneficial in preventing preterm birth in those groups (17,18). 

Research that disproves a current therapy or treatment can also provide valuable guidance to 

clinicians and their patients. Translational research in the 1990s found that the use of 

corticosteroids in pregnancies at risk of preterrn birth improved the outcomes for infants born 

preterrn, reducing the rates of breathing problems, bleeding into the brain, and problems with the 

intestines. However, the NICHD sponsored research that evaluated the use of repeated doses of 

corticosteroids, and found that they resulted in smaller birthweights and head circumferences 

(19). They also found a non-signitlcant, but concerning increase in cerebral palsy in children 

who were exposed to four or more courses of corticosteroids (20). This study, along with an NIH 

Consensus Development Conference to pull together all available data, stopped the routine use of 

repeated courses of antenatal corticosteroids (21). 

Vaginal infections have been associated in the scientific literature with preterrn birth. Previous 

studies showed that antibiotic treatment of symptomatic bacterial vaginosis in women with a 

previous preterm birth reduced the risk of recurrence. Based on this evidence, many womeneven those without symptoms of infection - were treated with antibiotics in an attempt to prevent 

preterm birth. However, a study supported by the NICHD's MFMU Network found that the use 

of a course of antibiotics in asymptomatic women did not decrease the risk of spontaneous 

delivery and did not result in improved neonatal outcomes (22). Another trial showed that 

screening and antibiotic treatment of all women with another type of vaginal infection 

(Trichomonas vaginalis) not only did not prevent preterm birth, but actually increased pretenn 

birth (23). These trials stopped the indiscriminate use of antibiotics in pregnancy. 

Evidence from European studies suggests that the omega-3 fatty acids found in cold water oily 

fish may reduce the chances of pre term birth. The NICHD's MFMU Network studied whether, 

in high risk women who are receiving weekly progesterone treatments, supplementation with 

two omega-3 fatty acids would result in an even greater reduction of preterrn birth than 

progesterone alone. The trial found that omega-3 supplementation did not further reduce preterm 

birth, halting an ineffective intervention (24). 

Antioxidants have been implicated in preeclampsia, a major cause of pre term birth. Although 

basic research suggested that antioxidants were beneficial, a trial evaluating supplementation 

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with Vitamin C and E did not prevent preeclampsia in 10,000 women in their first pregnancy, 

stopping the implementation of an ineffective therapy (25). 

In addition to studying preventative therapies, the MFMU Network studies antenatal 

interventions to prevent complications in premature infants. Recently, the network identified 

another therapy, antenatal magnesium sulfate (Epsom salts) which, when administered to women 

at risk of delivering preterm, reduces the risk of cerebral palsy in surviving preterm infants by 45 

percent(27). This finding was translated into clinical practice (28). Through the Network, the 

NIH also is supporting a new clinical trial to evaluate if antenatal corticosteroids will improve 

outcomes for women whose pregnancies are at risk for late preterm birth (34-36 weeks). Late 

preterm births account for 70 percent of pre term deliveries. The results of this trial may have 

substantial impact on the health of these infants. 

In addition, the NICHD and the Society for Maternal Fetal Medicine will hold a workshop in 

February 2011 to synthesize the available information regarding conditions that result in 

medically indicated late pretenn and early term births to determine the potential risks and 

benefits of continued pregnancy, the optimal gestational age for delivery (if optional), and to 

inform future research regarding these issues. 

Caring for Preterm Newborns 

Of the over 540,000 prematurely born infants in the US each year, more than five percent fail to 

grow appropriately in the womb due to placental insufficiency. Slow fetal growth, or fetal 

growth restriction (FGR), increases the risk of mortality and long-term neurological morbidity, 

including difficulties in infants' early learning. More than 70 percent of severe FGR infants 

develop learning disabilities and require special educational services. The NICHD is supporting 

research that will test the effectiveness of an intervention in the NICU for such infants, based on 

reducing overload on each baby's senses. 

Extremely low birth weight (ELBW) infants are at increased risk for developmental and 

behavioral abnormalities. The NICHD Neonatal Research Network, in a large study of very 

small infants in 15 sites, collected detailed information on breast milk intake of extremely low 

birth weight infants as part of a large trial of glutamine supplementation. Infants given breast 

milk had an increase in several developmental scores, making efforts to enhance breast feeding 

and provision of breast milk to ELBW infants a high priority. 

Nutrition and prevention of infection remain significant problems for this group of ELBW 

babies. Glutamine is one of the most abundant amino acids in breast milk and in blood, but is 

not included in standard solutions for intravenous nutrition. Glutamine showed significant 

promise in small human studies in adults for preventing infection and reducing death. Due to 

this finding, some intensive care nurseries had begun to supplement high-risk babies with 

glutamine. However, in the same Neonatal Research Network study, glutamine supplementation 

did not affect the rate of infection or the rate of death in the infants, providing sound information 

that glutamine supplementation for tiny babies should not be recommended at this time (29). 

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Nitric acid is a chemical compound that is sometimes used in its gaseous form to treat infants 

with severe breathing problems. Inhaled nitric oxide therapy was approved by the Food and 

Drug Administration in 2000 to treat term and near-term infants (born after the 33'd week of 

pregnancy) with respiratory failure. Since its approval, researchers have examined expanding 

the use of inhaled nitric oxide therapy to treat premature babies born at less than 34 weeks' 

gestation. Studies to evaluate its safety and efficacy for these infants have had mixed results(30, 

31). To better understand the potential risks and benefits of inhaled nitric oxide therapy for 

premature infants, the NIH will convene a Consensus Development Conference on October 27-

29, 2010, to assess the available scientific evidence and come to some conclusions about its use. 

Infant Mortality 

Infant mortality (6.7 deaths/l,OOO live births), stillbirths (6.2/1,000 live births), major birth 

defects (3011 000 live births) and preterm births (128/1,000 live births) are major public health 

priorities in the U.S (32). All ofthese already high rates demonstrate dramatic health disparities 

based on race-ethnicity with higher overall rates in African American women. Despite numerous 

efforts, the disparities are persisting. Researchers are attempting to identifY factors to explain the 

disparities, evaluating genetics, socio-economic status, accessibility to health care, maternal 

education, and stress and disease burden, among others. However, the complexity of the 

interactions among these factors has made the task more difficult. 

In August, 2010, the NICHD will hold a scientific workshop focused on disparities in infant 

mortality, stillbirth, and preterm birth. The goals of this workshop are to identifY the factors 

associated with such disparities and to determine their relative contributions and gaps in 

knowledge, and to design a plan for moving research forward in both the short and long term. 

Again, thanks to the Committee for your time and interest in this critical public health topic. 

am pleased to answer any questions you may have. 

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27 Rouse OJ, Hirtz DG, Thorn E, Varner MW, Spong CY, Mercer BM, lams JD, Wapner RJ, Sorokin 

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28. Magnesium sulfate before anticipated preterm birth for neuroprotection. Committee Opinion No. 

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29. Poindexter BB, Ehrenkranz RA, Stoll BJ, Wright LL, Poole WK, Oh W. Bauer CR. Papile LA, 

Tyson JE, Carlo W A. Laptook AR, Narendran V, Stevenson DK, Fanaroff AA, Korones SB, 

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12 
48 

Mr. PALLONE. Thank you, Dr. Spong. 

What we do now is, we have questions from the members for 5 

minutes or sometimes 8 if they didn’t do an opening, and I am 

going to begin with myself. 

I will ask initially Dr. Callaghan, in your testimony you discussed CDC’s role in surveillance in terms of monitoring infants 

born prematurely, analyzing trends, defining risk factors and targeting prevention programs. I mentioned that I sponsored H.R. 

3212, the Stillbirth and SUID Prevention, Education and Awareness Act, and I am particularly interested in the collection of critical data to determine the causes of stillbirth and sudden unexpected infant death. Can you tell me what the CDC is doing to understand the causes and risk factors associated with stillbirths, 

sudden unexpected infant death and sudden unexplained death in 

childhood, and are there ways to reduce those risks? And then secondly, how would better data collection help reduce and prevent 

these deaths in the future, if you could? 

Dr. CALLAGHAN. The National Center for Health Statistics collects information on fetal deaths from fetal death certificates. Fetal 

death certificates are not birth certificates. A fetal death report is 

what it is called. So they are able to—those are collected by States, 

sent to NHS and NHS compiles those for the Nation. The quality 

of information on fetal death certificates is not always what we 

would hope it would be. These are filled out essentially in real time 

at the bedside in the hospital and sent in, and there is a fair 

amount of variability in how stringently people fill those out. There 

is also a fair amount of variability on how much each fetal death 

is investigated at the individual level. To do this correctly, there 

needs to be fetal autopsy, there needs to be fetal genetic studies. 

These aren’t always done consistently and so the amount of information that is ultimately reported as to the cause of death can be 

variable, which leads us to your statement that in many cases we 

are left without a real good reason about why that happened. So 

efforts to improve the quality of fetal death reporting at each individual level at the time of each individual fetal death would be important in terms of improving our information. 

There is also some pilot work that is being done at CDC at Atlanta in the National Center for Birth Defects and Developmental 

Disabilities. There is Atlanta Metropolitan Birth Defects Surveillance System and there is some pilot work being tagged onto that 

to try to see if fetal death registration can also be used with that 

same infrastructure. If that was successful, that could be expanded 

to other birth defect surveillance systems. Birth defect surveillance 

systems collect much more nuanced information, almost through 

survey. 

Lastly, about sudden unexplained infant death, we have done a 

lot of work in this area, and we have learned that there is a difference between the sudden unexplained infant death and sudden 

infant death syndrome. Sudden infant death syndrome means 

there is no plausible explanation for the cause of death. It is truly 

unexplained. The more and more that people do death scene investigations on the ground, again, in and around the time of the infant 

death, the more and more people are finding that there actually 

may be explanations. The good thing about having an explanation, 


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it doesn’t bring a lot of relief to the grief of parents, but if you have 

an explanation, now we have a chance of prevention. So we are in 

the process of establishing pilot registries for that. 

Mr. PALLONE. Thank you. 

I am going to try to summarize this next one for Dr. Spong. I 

think it is critically important that we do everything we can to ensure that we have the right research infrastructure and so I wanted to ask you three questions about the research network. First, 

how many women are usually in the clinical trials conducted by the 

network? I guess we are talking about the Maternal Fetal Medicine 

Unit Network. And is there a diverse population of women represented in the trials? Can you elaborate on use of 17P to prevent 

prematurity and would you discuss other interventions that have 

impacted patient care to date? 

Dr. SPONG. Thank you, Mr. Chairman. The first question was the 

number of patients enrolled in clinical trials? 

Mr. PALLONE. How many women are usually in them, yes, and 

is there a diverse population of women? 

Dr. SPONG. So the number of patients enrolled in a given trial 

depends on what the trial is looking at and what the question is 

to be addressed, how big the effect needs to be, how rare the outcome is. We have had trials that have included few number of patients, for example, 200, 300, and we have recently completed a 

trial that included over 10,000 women. In addition, some of the observational studies have included, you know, many, many more 

women than that. The diversity of the population is assured when 

the network is openly and actively recompeted every 5 years. As 

part of that recompetition, as part of looking at who should be part 

of the network includes geographic diversity and diversity in the 

patient population. 

Your question about 17 alpha hydroxyprogesterone caproate or 

progesterone for the use to prevent preterm birth, this was a landmark study as the first preventative therapy identified for women 

who had a prior preterm birth. As a clinician, I knew that one of 

the very common things that you would see with a patient who had 

come in for prenatal care who had had a prior preterm birth, we 

would say that you are at very high risk for another preterm birth 

but we had nothing to offer her. Now with the use of 17 alpha 

hydroxyprogesterone caproate, we have something that we can 

offer her that can reduce her risk of another preterm birth by 

about one-third. That progesterone is now being studied in other 

high-risk populations so women who have had a prior preterm 

birth or are at high risk, women who have multiple gestations are 

at high risk, and they have been studied, both women with twins 

and triplets, and it was found that progesterone did not reduce the 

rates of preterm birth in that population, and I think that is very 

important to know, that it is not a cure-all for all prematurity, it 

is for specific conditions and it is currently being evaluated in the 

setting of a shortened cervix in an asymptomatic woman. 

There are a number of other studies that the network has undertaken that have impacted practice. One example is the use of 

antenatal corticosteroids which are given to women who are risk of 

delivering preterm with the understanding that it will improve outcome for the babies. It decreases their complications such as 


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breathing complications and bleeding complications. The network 

undertook a study looking at repeated doses of those steroids and 

found that in fact that was not beneficial, so it was a change in 

practice from repeating multiple doses of steroids. 

Another example is one of magnesium sulfate being administered 

to women who are at risk for preterm birth where it significantly 

reduced the risk of cerebral palsy by about 45 percent. One of the 

unique factors from this network is that when these trials are published, their findings are then often incorporated into professional 

guidelines such as those by the American College of Obstetricians 

and Gynecologists making recommendations for how that should 

change and how that should be implemented into practice. I can 

give a number of other examples as well. 

Mr. PALLONE. No, I think we better stop there because I made 

you go over. It is not your fault. 

Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

I want to throw this out there. In the health care law, either I 

am right that my constituent is denied the ability to purchase insurance on the sole reason of a preexisting condition of their child, 

or I am wrong, and I would ask someone on the majority side to 

help me have a hearing on this issue to see who is right. It is not 

a question. I am asking for a hearing. I have a case of a former 

staffer who cannot get insurance because of a preexisting condition 

of their child. My colleague from Illinois said that is not true, and 

I think this would be a good hearing to have on this issue of whether people right now under this health care law are being denied access because of preexisting condition. So I want to put that on the 

record. My colleague is not here from Illinois, who rejected my 

claim, but I throw that out as an issue. 

I appreciate your testimony, and you say words I can’t even pronounce, but I do have a question, Dr. Spong. The mission of the 

NICHD is to ensure that every person is born healthy and wanted, 

and I am curious of why you have the word ‘‘wanted’’ there. What 

does that mean and what does that mean for what you do? It is 

a curious word. Can you explain that? 

Dr. SPONG. Thank you for your question. The question is why the 

NICHD mission includes the word ‘‘wanted,’’ and I will be the first 

to admit that the mission was created before I started working at 

the National Institute of Child Health and Human Development so 

I do not have that information for you at this time, but I would be 

happy to get back to you in written testimony. 

Mr. SHIMKUS. Yes, it is an interesting word. I mean, I don’t know 

what it means. So if you could get back to me. Before we make conjectures and think things, I will just wait for a response because 

I just don’t know what that means. 

Let me follow up with this question. If individuals change their 

lifestyle, stop smoking and manage their weight, would that reduce 

the risk of prematurity, Dr. Spong? 

Dr. SPONG. The risk factors that you stated were if they lost 

weight and if they stopped smoking, would that reduce preterm 

birth. Obesity itself—healthy lifestyles are good for pregnancy. 

Obesity itself has a mixed message on whether or not it actually 

causes preterm birth. There are studies that would suggest that 


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obesity is not in fact associated with preterm birth. That said, 

starting out with a healthy weight is optimal for pregnancy for a 

number of reasons regardless of preterm birth, so we would certainly encourage all women to start pregnancy at a healthy weight. 

Smoking itself is associated with low birth weight or smaller babies, and clearly is one major lifestyle change that people can make 

that can improve the health of their children and remove the risk 

of low birth weight. 

Mr. SHIMKUS. Let me follow up, because Dr. Callaghan mentioned that infection itself may not be the cause of prematurity but 

rather the inflammation associated with the infection. Do you 

agree with that? 

Dr. SPONG. The question regards to the role of infection versus 

inflammation on preterm birth, and preterm birth is a very complex condition, and I believe there are multiple pathways that can 

lead to a preterm birth. One is going to be an infectious pathway. 

Clearly, that can cause preterm birth but the inflammation itself 

in the absence of infection can also cause preterm birth. 

Mr. SHIMKUS. And then are there contributing factors to increased inflammation that could be avoided through a change in 

lifestyle? 

Dr. SPONG. That is an excellent condition. Those are areas that 

are currently getting teased out. It is likely that it is not a single 

factor that causes much of preterm birth but a constellation of 

events, so whether you have certain environmental factors, certain 

genetics, certain inflammatory markers and then certain lifestyle 

events that can ultimately result in a preterm birth. 

Mr. SHIMKUS. And I want to thank you. I am going to end. Of 

course, on our side we have Dr. Gingrey and Dr. Burgess, who are 

both obstetricians, and I am waiting for their follow-up questioning 

as they are experts in the field, and I yield back my time. Thank 

you, Mr. Chairman. 

Mr. PALLONE. Ms. Capps asked that we enter into the record this 

letter from Secretary of Health and Human Services to the Speaker 

and I guess to the Republican leadership, and it basically goes into 

the different provisions in the health care reform on adult and 

child coverage, preexisting conditions, early retirement, reinsurance, rescissions, Medicare Part B with a timeline. 

Mr. SHIMKUS. That is correct. The point that Secretary Sebelius 

has said please, insurance companies continue to cover people, kids 

with preexisting conditions. The issue is they are not, and so I 

would suggest that we have a hearing on this, and—— 

Mr. PALLONE. I am not just reading it. 

Mr. SHIMKUS. I am just—— 

Mr. PALLONE. You know what it is. 

Mr. SHIMKUS. I am just—— 

Mr. PALLONE. Effective beginning—— 

Mrs. CAPPS. The date September 23rd is there. 

Mr. PALLONE. And on March—— 

Mr. SHIMKUS. So right now people if they have no insurance, 

they cannot get coverage with preexisting conditions. That is the 

law. 

Mrs. CAPPS. Because some insurance companies are operating to 

do it—— 


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Mr. SHIMKUS. So you are not disputing the fact that my former 

staffer, this family cannot get health insurance right now? 

Mrs. CAPPS. It isn’t required yet. 

Mr. SHIMKUS. It is not required. Thank you for—— 

Mrs. CAPPS. But it will be very soon. 

Mr. PALLONE. But on March 29th it is required for children. 

Mr. SHIMKUS. But it is now right now. 

Mrs. CAPPS. September 23rd. 

Mr. SHIMKUS. But it is not right now. 

Mr. PALLONE. It says on March 29th—— 

Mr. SHIMKUS. So my point is, we could pass a law tomorrow to 

do this. 

Mr. PALLONE. Well, Mr. Shimkus, first of all, does anybody have 

an objection to entering this into the record? I mean, the only thing 

it says on preexisting conditions, it says, ‘‘Effective for policies or 

plan year beginning on or after September 23rd be prohibited from 

excluding coverage of children.’’ 

Mr. SHIMKUS. If the chairman would yield, my point is, I am 

going to continue to raise issues that we ought to have hearings on 

this law, and this is just another example of people not having access to health insurance because of preexisting conditions, and this 

is something we can fix. 

Mr. PALLONE. I don’t think there is any question that the law is 

the September date, but you can look at it. 

Mr. SHIMKUS. And we could bring a bill to the floor tomorrow 

and fix this. That is my point. 

Mr. BURGESS. Mr. Chairman, if I could just stand in agreement 

with my colleague from Illinois. We handed an enormous task to 

the Department of Health and Human Services to create something 

out of whole cloth in this law that we passed hurriedly a couple 

months ago and really it is incumbent upon this committee to 

maintain the vigilance and oversight over HHS and CMS as they 

come up with these rules and regulations that are literally going 

to affect every American, not between today and Election Day but 

for the next three generations. So I hope you will consider Mr. 

Shimkus’s request to hold the appropriate hearings at this level. 

Mr. PALLONE. Let me just have that back. 

Without objection, it is entered into the record. 

The gentlewoman from California has the time. 

[The information appears at the conclusion of the hearing.] 

Mrs. CAPPS. Mr. Chairman, you may not wish to call on me after 

all of that, but thank you. This has been a good discussion. Back 

to the topic, but before I ask my question for Dr. Callaghan, I want 

to just acknowledge that there are many members of a non-governmental organization called CARE on Capitol Hill today because 

they are very interested not only in this hearing but in other topics 

having to do with preterm delivery and birth, and one of them is 

a constituent of mine so I want to welcome a particular group that 

was here. We had nurses earlier as well. And I appreciate the testimony that both of you have given us. 

Dr. Callaghan, in your testimony you included some of the surveillance mechanisms that the CDC uses to monitor the pregnancy 

outcome and also infant health. Especially with issues such as the 

ones we are discussing today, I believe it is critical to have really 


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accurate and robust surveillance and data collection strategies. 

Now, you mentioned that only 37 States and New York City participate in what is called the PRAMS program and that the survey 

is representative is 75 percent of all births. It is too bad we can’t 

have closer to 100 percent. What are some of the barriers to implementation of this participation in all States and for full representation so that we really have a much more robust data collection? 

Dr. CALLAGHAN. The one thing I will say, and this is very pertinent to your state, is California has a very complementary system 

that does not participate in PRAMS. I could get the precise name 

of it. I think it is called MEWA. 

Mrs. CAPPS. So we do something different but you can’t use it in 

the national data collection? 

Dr. CALLAGHAN. No, we cannot use that in the national data collection. That is parochial to California. It is a very good system. 

Mrs. CAPPS. The California system is good but it doesn’t help nationally? 

Dr. CALLAGHAN. It doesn’t help nationally. 

Mrs. CAPPS. I see. So that in of the barriers then? 

Dr. CALLAGHAN. It is a barrier because—— 

Mrs. CAPPS. And so maybe some kind of smart scientist can figure—a number cruncher can figure out how to coordinate it so it 

will be useful to California but also to the United States. 

Dr. CALLAGHAN. Because then one of the other problems that is 

left with some of the other smaller States is the births are so small, 

and this is based on not a sampling of total births but on a sample 

of births and so some very small States, it becomes very difficult 

to get a sample that is representative. 

Mrs. CAPPS. And you really want to have a large State like California and all of New York, not just New York City involved? 

Dr. CALLAGHAN. Right. 

Mrs. CAPPS. That is useful. Thank you very much. It gives me 

something to think about with my own State. 

Here is another question. I am very excited to hear of the move 

to modernize vital records systems. Maybe this is one arena where 

we need to do this. But there seems to be more room for data collection. Can you tell us more about what is currently being collected on electronic records in light of the many factors? Maybe we 

are not even asking enough questions when we do data collection. 

In light of the many factors associate with premature birth and infant mortality and morbidity, what other data would be helpful to 

collect? Especially with the kind of technology we have to collect 

and sort data. 

Dr. CALLAGHAN. You are asking what other information could we 

collect on birth certificates? 

Mrs. CAPPS. Are we lacking—— 

Dr. CALLAGHAN. We collect a lot of information on birth certificates. We collect a lot of information about maternal conditions 

during pregnancy. We collect information about problems that occurred during labor and delivery. But one of the things that we 

have seen over and over again when we go back and do validation 

of that information is that it doesn’t do very well most of the time. 

Mrs. CAPPS. So there is room for improvement? 


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Dr. CALLAGHAN. There is room for improvement at the level of 

data collection, and data collection occurs individually at individual 

hospital level. 

Mrs. CAPPS. So there might be some legislation that would be 

useful to you to help with the CDC to do a better—to be more 

equipped to do a better data collection? 

Dr. CALLAGHAN. I have always said that if there is anything that 

I could do in career in public health is to improve vital statistics 

because we have an infrastructure in place. 

Mrs. CAPPS. Mr. Chairman, I am going to suggest, or just suggest 

it to my fellow committee members that this is an area that would 

seem to be the low-hanging fruit, if you will, for some of the challenges that we face in this area, that if we can put some bright 

heads together to figure out a better way to collect data and use 

it in a proper way, that would be very useful. 

I am going to try one more question because I have 17 seconds. 

Dr. Spong, I appreciated your testimony as well. You know, there 

are so many factors associated with preterm birth, the health status of the mother, you know, issues like diabetes, obesity, deficiencies of certain nutrients and so forth, high blood pressure. Can 

you just say in a couple of seconds more about the importance of 

preconception health? This is such a huge issue that starts really 

prebirth with the one-day mother, doesn’t it? 

Dr. SPONG. Yes, preconception care is clearly important. Women 

who start pregnancy healthy tend to have healthier pregnancies. 

That said, I cannot point to research or data as to what exactly 

needs to go into that preconception care that will actually ultimately result in improved outcomes. But we do know that women 

who have a healthy lifestyle, who are an appropriate weight, who 

don’t have habits such as smoking or alcohol exposure tend to have 

healthier pregnancies. 

Mr. PALLONE. Thank you. 

The gentleman from Pennsylvania, Mr. Pitts. 

Mr. PITTS. Thank you, Mr. Chairman. First, I would like to ask 

unanimous consent to enter into the record a couple of articles and 

a list of studies that have found that women with prior induced 

abortions are at increased risk for premature birth and low birth 

weight. 

Mr. PALLONE. I am going to take a look at them but I don’t see 

a problem. 

Mr. PITTS. The articles are by the American Association of OB/ 

GYNs. 

Mr. PALLONE. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. PITTS. Thank you, Mr. Chairman. 

Dr. Callaghan, you mentioned that the CDC had worked with 

States to assist with smoking cessation programs during pregnancy. Have any States used their master settlement agreement 

funds to implement smoking cessation programs targeted at pregnant women? 

Dr. CALLAGHAN. I really don’t have the information at hand to 

answer that question. I would be happy to do that and get that information to you. 


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Mr. PITTS. All right. You mentioned that African American 

women are more than, I think you said twice more likely than 

white women to have preterm birth, one and a half times more 

likely to have preterm birth, twice as likely to have very preterm 

infants. Why is that the case? 

Dr. CALLAGHAN. That is one of the holy grails. Understanding 

that is probably one of the holy grails in all of perinatal health and 

perinatal medicine. These are disparities that we have seen over 

and over and over again. They are pernicious. When we adjust for 

almost anything that we can think of, if we adjust for socioeconomic status, we adjust for education levels, it doesn’t go away. 

In fact, as was mentioned previously in this hearing, these gaps are 

even greater when we look at the difference between the most welloff African American women and the most well-off white women, 

the gap is even greater. As Dr. Spong mentioned, the paths to 

preterm birth are likely very, very complex. This has been likened 

to this other group of diseases that we call common complex diseases like cardiovascular disease where at the end of the day there 

is a preterm birth but there are a lot of different ways to get there. 

Our current kind of working hypotheses around these, that there 

are genetic factors, that are environmental exposures, environmental in most holistic ways such as stress, poverty, all of which 

are interacting to result in whatever happens that goes into spontaneous preterm birth. If we knew the answer to that question and 

if we could fix that problem, our preterm birth and our infant mortality rate would be dramatically decreased in the United States. 

Mr. PITTS. And in 2006, Congress passed the PREEMIE Act authored by Mr. Upton in the House, and one provision of the legislation called on HHS to award grants to public and private nonprofit 

entities to conduct demonstration projects for the purpose of improving the provision of information on prematurity to help professionals and the public and improving the treatment and outcomes 

for babies born preterm, and the grants were to support programs 

to test and evaluate screening for and treatment of infections, 

counseling on optimal weight and good nutrition, smoking cessation, education, counseling, stress management, appropriate prenatal care. How many grants have been awarded under this program and what have been the results of these demonstration 

projects so far? 

Dr. CALLAGHAN. We began receiving appropriations for the 

PREEMIE Act in 2009, and we have continued to do work in 

preterm birth as I outlined with regard to looking at late preterm 

birth, with looking with factors associated with the interactions 

that we are looking at in California, looking at in Michigan, the 

interactions between preterm birth, race, genetic factors and biologic markers. There are people at CDC that are working in authorization and appropriations and I would be happy again to have 

them get back in touch with you, but as the scientific liaison for 

the branch that I work in, that is information I am just not familiar with. 

Mr. PITTS. OK. 

Dr. Spong, I don’t have much time. You mentioned genomic research in the filed of prematurity. Can you further expand about 


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what we have learned about prematurity from genomic perspectives? 

Dr. SPONG. There have been a number of smaller studies looking 

at specific genes or specific alterations in genes to try to identify 

why one group might be at higher risk of delivering preterm, and 

they have identified certain changes in alleles or changes in genes. 

However, we realize that really that is not going to answer the 

question, looking at small groups of people one gene at a time or 

one alteration in a gene at a time. Because of that, the NICHD undertook launching a network on genomics and proteomics of 

preterm birth to try to really do a genome widescreen and really 

evaluate what are the changes in the genomics and proteomics associate with spontaneous preterm birth and indicated preterm 

birth, and that network is ongoing and over the next couple of 

years I expect we will have some findings from it. 

Mr. PITTS. Thank you. My time is expired. 

Mr. PALLONE. Thank you, Mr. Pitts. 

I guess we are going to the gentlewoman from Florida, Ms. Castor. 

Ms. CASTOR. Thank you very much for your testimony. 

Dr. Callaghan, correct me if I am wrong, but I believe there is 

no conclusive evidence that links rising C-section rates to prematurity numbers or data that displays that increases in C-sections are the reason that prematurity rates went up from 1996 to 

2007. However, the speculation is strong. The March of Dimes reported that from 1996 to 2006, C-sections accounted for 92 percent 

of all preterm births in the United States. Can you please discuss 

the type of studies that must be conducted to get to the bottom of 

this and what steps are currently underway? 

Dr. CALLAGHAN. First of all, because I was a coauthor on that 

paper, it is really 92 percent of the increase in preterm births and 

not the total preterm birth rate. Still, that is a very compelling 

number. The issue about this really hinges around the word 

‘‘cause.’’ During this time, 1996 through now in fact, Cesarean sections have been rising for all comers and pregnancy no matter 

what the gestational age, perhaps more particularly in the late 

preterm births but it is going up. I think that the issue around 

cause, and maybe we need to look at this a little bit differently, is 

not so much as a Cesarean section that is caused but might we expand that a little bit more to say is it intervention because there 

are other decisions that are being made around delivery. And I 

think that is what we need to get at, what kinds of decisions are 

being made. There are always two steps in this process. The first 

step on a clinical basis is the physician and the patient together 

in the best circumstances make a decision that delivery should 

occur. So that is the first thing that happens is should delivery 

occur. Next question is how delivery should occur. So I think that 

first step, should an intervention take place, is what we really need 

to get at. One of the things that we are doing right now is, we have 

a pilot study in three metropolitan Atlanta hospitals. We are going 

to identify through vital records a group of infants that were born 

between 34 and 36 weeks, go to the medical records and see if it 

is even possible by looking through the medical records to find a 

reason why the birth occurred. We are also planning on doing some 


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key informant interviews in those hospitals, physicians, nursing 

staff, et cetera, to try to get some more qualitative information 

about what might be influencing those decisions because I think 

what we really need to do is get at these processes, and this is hard 

stuff because this isn’t just numbers, it is really getting around 

qualitative information about what process goes on when decisions 

are made to deliver prior to term and then how delivery should 

take place. 

Ms. CASTOR. You know, ACOG and the March of Dimes have 

probably the best recommendations on protocols for health providers. It sounds like the study in Atlanta, something along those 

lines so you support something like that on a broader basis as well. 

Yes? 

Dr. CALLAGHAN. Yes. 

Ms. CASTOR. Thank you very much. 

Mr. PALLONE. Thank you. 

The gentleman from Texas, Mr. Burgess. 

Mr. BURGESS. Well, I am actually glad that subject Ms. Castor 

brought up, that you are having that discussion. In 2006 when we 

reauthorized the National Institute of Health, there was report language in the bill dealing with the concept of doing a Cesarean suction study. Dr. Ken Leveno down at Parkland where I trained had 

been concerned that there was a movement toward elective Cesarean section. In my professional lifetime, I saw rates go from 12 percent during my residency to probably 25 percent when I concluded 

active practice in 2003 and now I suspect they are even higher still. 

Dr. Leveno’s concern was, we may reach a point where simply the 

indication for Cesarean section is patient demand, and we really 

ought to have the data before we reach that point because once we 

are there, it then becomes very hard to walk back from patient demand on something along those lines. So where are we with that? 

Are we looking into the concept of Cesarean section rates and elective Cesarean sections are the rates of late prematurity which are 

a result of some iatrogenic influences either with Cesarean section 

or planned induction of labor? Do you have data on those issues? 

Dr. CALLAGHAN. Yes, that is exactly what we are trying to get 

at now with these studies. There is also another study that I am 

involved in peripherally through wearing my CDC hat in Florida 

that is trying to look at that exact issue. There are no national 

data on Cesarean section on demand. 

Mr. BURGESS. Again, it was Dr. Leveno’s concern that we ought 

to get that data before it becomes an established norm. I would 

never be able to go back and randomly assign people to groups. I 

mean, you know that. It becomes almost an impossible study to 

construct, so we ought to be prospective about our look at that. 

Dr. CALLAGHAN. And that would probably to do that on a national basis to include all deliveries in the United States would 

likely demand really changing our birth reporting forms to have 

that as a check box, if you will, or questions on that regarding the 

indications for Cesarean delivery. To the degree that could be done, 

I would be in wholehearted support. I don’t know logistically if that 

is going to happen very quickly. 


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Mr. BURGESS. Yes, it is expensive to do that type of study. Honestly, it may be something that we need to look at in a prospective 

fashion. 

I represent a part of north Texas, the east side of Fort Worth. 

Fort Worth is where the west begins, but I have the east side. That 

is where the east levels out. We have some infant mortality rates 

in some of my zip codes that are some of the highest in the country, 

and if you look at African American women and the infant mortality rates for African American populations in those zip codes, it 

is astoundingly high, and yet on the other side of the Trinity River 

in Dallas, their mortality rates are much more benign and you 

don’t see the ratio of disparities. Both counties are large. Both have 

significant urban populations. Both have a county hospital. The difference between the two is the availability and the access to what 

might be referred to as a community clinic or federally qualified 

health center. And I have labored for that since 2005 when I began 

representing that part of Fort Worth, to get a federally qualified 

health center there. We did not quite a year so, so it will be a while 

before we see if it makes a difference, but it really drove home to 

me that access may be a problem, and that is something we need 

to pay attention to, but arguably there is equal access in Dallas 

and Tarrant counties because of the availability of a county facility 

even for someone who lacks the ability to pay, and these are taxsupported institutions. But utilization was hugely different between Dallas and Tarrant County, and I think I attribute part of 

that to the fact that the availability, the doctors weren’t where the 

people were, and that has been one of the difficulties that I have 

sought to outcome. Do you guys have any experience with looking 

at things like that? 

Dr. CALLAGHAN. We don’t have a lot of experience with looking 

at that particular thing although I think you are probably referring 

to your home base, the Parkland experience and the report that 

they have about reducing preterm birth and infant mortality and 

it is an intriguing model where it is almost doing prenatal care as 

I read that almost as community outreach. 

Mr. BURGESS. And interestingly, back in the 1950s, Dr. Prichard, 

looking at a map of Dallas and putting a pin in the map, a very 

low-tech activity but a pin in the map every time an out-of-hospital 

birth occurred, and that’s where he set up the clinic after he got 

a cluster of pins, and we as residents would rotate through those 

clinics back in the 1970s. So they have a longstanding robust outpatient clinic department that is well accepted in the community 

because it has been there now for almost 50 years. Again, on the 

other side of the Trinity, we don’t have—that is not an established 

part of what people think about. When they think of John Peter 

Smith, it is because it is the county hospital, not because there is 

a community clinic that feeds into that. I just think, you know, we 

talk about how we spend money, we have got to spend money wisely, I just think that is one of the areas where we perhaps missed 

an opportunity in this health care bill that we did. Well, we missed 

a lot of opportunities, but an opportunity we missed in this health 

care law was recognized in that. 

Thank you, Mr. Chairman. You have been indulgent. I will yield 

back the balance of my time. 


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Mr. PALLONE. Thank you. 

The gentlewoman from the Virgin Islands, Ms. Christensen. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. I would like to 

ask unanimous consent to insert into the record written testimony 

from Dr. Paula Braveman, professor of family and community medicine at University of California San Francisco. 

Mr. PALLONE. What is it that you are giving me again? 

Mrs. CHRISTENSEN. Written testimony that I would like to insert 

into the record of today’s hearing. 

Mr. PALLONE. Oh, OK, from—— 

Mrs. CHRISTENSEN. Dr. Paula Braveman. 

[The information appears at the conclusion of the hearing.] 

Mr. PALLONE. Without objection, so ordered. 

Mrs. CHRISTENSEN. Thank you. And just for the record, and I 

know this is not NIH but it is really CDC, but I see no reason why 

the territories’ infant mortality, low birth weight and preterm deliveries are not reported on because we have that data, and I am 

proud to say that our infant mortality in the Virgin Islands last 

quarter was 7.56, and I can say I am proud because I know where 

we came from to get to 7.56, and that is in a largely African American and Puerto Rican community. 

Mr. SHIMKUS. Would the gentlelady yield for one second? I think 

it would be good for the Administration, because she has raised 

this a couple times that they better be prepared to report on the 

territories when they come to this committee. We are glad to have 

her on the committee. 

Mrs. CHRISTENSEN. Thank you. 

Dr. CALLAGHAN. I will be happy to take that back to National 

Center for Health Statistics. 

Mrs. CHRISTENSEN. Thank you. And thank you, both of you, for 

raising the issue of the disparities in African Americans that I 

didn’t have to do my opening statement. 

Dr. Callaghan, what is puzzling and has been known for a while 

is that even in African American women who are well off, well educated, live in supportive surroundings, there is still a higher low 

birth weight baby. They still have higher rates of low weight babies. Is there research being done to determine why this is and are 

you coming up with—this is sort of following up on the other question, but this is low birth weight babies, not preterm necessarily, 

not necessarily infant mortality. 

Dr. CALLAGHAN. I came to CDC in 2001. Even prior to me coming 

there, there has been a long history of CDC bringing people together to look at this problem. A lot of the work in what is the social context of pregnancy in African American women and what is 

the context of African American women in the United States and 

looking at the long-term effects of institutionalized discrimination 

and institutionalized race and how does that chronic stress, which 

is very difficult to measure, there is not a blood test for it, but we 

know from some qualitative work that that stress exists and we 

also know that chronic stress plays itself out biologically. There is 

no question about it. Stress is a biologic phenomenon. There are 

pathways between what is going on in our brains and our brains 

are connected to everything, and there has been the hypothesis 

that some of these stress hormones actually regulate what has 


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been euphemistically called the placental clock, and that there may 

be messages coming down that it is time to be born that are not 

in the best interest of the woman or the baby but that is what is 

going on. That being said, when we start drawing these pathways, 

there are so many lines feeding back on to one another that they 

are almost not even lines anymore, they are this line going up, this 

line going down and all of a sudden the line becomes a plane. 

The more important thing perhaps might be not so much the recognition that stress plays a part but then in the next step so what 

do we do about this, how can we ameliorate the effects of chronic 

stress, almost a bigger problem than trying to understand that 

stress affects our biology. We have done—— 

Mrs. CHRISTENSEN. Are you actually testing women in any way 

to see what their level of stress is? You are talking about people 

who are working in great jobs, have a decent education, and I 

mean, everybody has stress. 

Dr. CALLAGHAN. Right, and in fact, when we look at least 

epidemiologically, we see that women who like in PRAMS, for example, they ask a lot of question about individual stress and individual stress is much worse when you sort of overlay their neighborhood context, for example, people who live in poor neighborhoods have a more profound response to stress, at least as it relates to preterm, than women who don’t. I would like also Dr. 

Spong to weigh in because NIH is doing a lot of that fundamental 

work as well. 

Mrs. CHRISTENSEN. And before you answer, though, let me just 

get my second question which is to you, Dr. Spong, and we are glad 

to hear about the August conference that you are having. In your 

answer, could you also tell me if the trials with magnesium sulfate, 

progesterone or treatment of bacterial vaginosis, if those trials 

are—the people in those trials, are they diverse enough to be able 

to tell the impact on African American and Latino or American Indian? 

Dr. SPONG. I thank you for both of your questions. I am going 

to take the second question first. The diversity of the patient population in the network is required by the open recompetition every 

5 years that the sites are geographically diverse and the population 

is geographically diverse. And I think one of the best examples is 

that progesterone was found to be equally beneficial in both African American women and non-African American women, which is 

so important given the disparities associated, so yes, we do strive 

for that and we are achieving that at least at this point. 

I would like to bring to your attention one study that the NICHD 

currently has underway called the community child health research 

network, which is focused specifically on the question you are asking about the African American community disparities in preterm 

birth as well as infant mortality, and the goal of this network is 

to involve the community itself along with the academic sites to develop the interventions to try to see if we can understand the disparities when measuring these markers of stress and to try to see 

if we identify potential interventions. 

Mrs. CHRISTENSEN. Thank you. Thank for your answers, and Mr. 

Chairman, thank you. I yield back the balance of the time I have 

left. 


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Mr. PALLONE. I think that completes the questions for this panel. 

Thank you very much. It was helpful in terms of what we are trying to achieve and we appreciate it. We may send you additional 

questions from some of the members within the next 10 days to answer in writing as well. But thanks. 

I will ask the next panel to come forward. Let me introduce the 

three of you. First on my left is Dr. Alan R. Fleischman, who is 

senior vice president and medical director of the March of Dimes 

Foundation. And next to him is Dr. Charles S. Mahan, who is dean 

and professor emeritus of the USF College of Public Health, the 

Lawton and Rhea Chiles Center for Healthy Mothers and Babies. 

Thank you for being here. And finally, Dr. Hal Lawrence, who is 

vice president for practice activities of the American College of Obstetricians and Gynecologists. Thank you, Dr. Lawrence. 

As you know, we ask you each to speak for about 5 minutes and 

then later if you want to submit additional materials in writing, 

you can. 

We will start with Dr. Fleischman. 

STATEMENTS OF ALAN R. FLEISCHMAN, MD, SENIOR VICE 

PRESIDENT AND MEDICAL DIRECTOR, MARCH OF DIMES 

FOUNDATION; CHARLES S. MAHAN, MD, FACOG, DEAN AND 

PROFESSOR EMERITUS, USF COLLEGE OF PUBLIC HEALTH, 

LAWTON AND RHEA CHILES CENTER FOR HEALTHY MOTHERS AND BABIES; AND HAL LAWRENCE, MD, VICE PRESIDENT, PRACTICE ACTIVITIES, AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS 

STATEMENT OF ALAN FLEISCHMAN 

Dr. FLEISCHMAN. Thank you, Chairman Pallone, Ranking Shimkus and members of the subcommittee. On behalf of the 3 million 

volunteers and 1,400 staff members of the March of Dimes, I want 

to thank the committee for your interest in the public health crisis 

of premature birth. 

As you know, the March of Dimes is a national voluntary health 

organization founded in 1938 by President Franklin Delano Roosevelt to prevent polio. Today, the foundation works to improve the 

health of mothers, infants and children by preventing birth defects, 

premature birth and infant mortality through research, community 

services, education and advocacy. 

After 3 decades of continual increases in the rate of prematurity, 

the March of Dimes is heartened by the news that the rate of 

preterm birth has finally leveled off and has begun to decline. But 

now is not the time to rest on our laurels. The life-threatening and 

lifelong consequences of prematurity as well as its extraordinary 

costs in dollars can still be felt by more than half a million babies 

and their families and each year in the United States some 28,000 

babies die before the first year of life due to preterm birth. Prematurity is also the number one cause of neonatal death and is the 

major contributor to infant mortality. It is responsible for lifelong 

disabilities. 

We have also learned that the complications of being born late 

preterm, just four to six weeks premature at 34 to 36 weeks’ gestation are also significant since one-third of brain growth and develVerDate Mar 15 2010 02:39 Feb 16, 2013 Jkt 076576 PO 00000 Frm 00067 Fmt 6633 Sfmt 6633 E:\HR\OC\A576.XXX A576

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opment occurs in the last 5 weeks of pregnancy. Infants born just 

4 to 6 weeks early are more likely than term infants to have significant long-term deficits such as school learning problems, disabilities and lower rate of college education and lower net incomes. 

In addition to the severe consequences, the costs of prematurity 

are immense. The Institute of Medicine estimated the annual societal economic costs associated with preterm birth are at least $26 

billion a year. Approximately half, or 48 percent, or hospital stays 

for preterm infants are financed by Medicaid. In 2007, hospital 

costs for these babies averaged $45,900 each. 

In recent years, we have seen several effective interventions to 

decrease preterm birth through comprehensive quality improvement strategies. The Intermountain Health System in Utah initiated prospective review of all elective inductions and C-sections 

and were extremely successful with dramatic decreases in early deliveries. Parkland Hospital in Dallas universal access to culturally 

sensitive comprehensive perinatal services over the past 15 to 20 

years including high-quality, evidence-based care with accountability and continuous quality improvement has resulted in the 

lowest rates of preterm birth among African Americans and indigent Hispanics in the United States. 

For the March of Dimes, the Cesarean section question is simple. 

Every baby should be delivered at the right time for the right reason. We applaud the guidelines and efforts of the American College 

of Obstetricians and Gynecologists. Adherence to their current 

guidelines and holding hospitals and clinicians accountable to these 

standards of care through quality and safety initiatives in hospitals 

can make a major difference in the rate of preterm birth and is 

needed in every hospital in the United States. 

So we are beginning to see some progress, but to sustain and to 

be truly successful in reducing the incidence of preterm birth and 

infant mortality, we require the continuing commitment of the federal government. That is why the March of Dimes is seeking reauthorization of the 2006 PREEMIE Act to support expanded research, education and demonstration projects. My written testimony provides more specific recommendations, but let me be clear: 

First, further research is essential into the fundamental causes of 

prematurity, and as the Institute of Medicine report and the surgeon general’s conference recommended, transdisciplinary research 

centers for prematurity funded by the National Institutes of Health 

with new dollars allocated for these activities will integrate a wide 

range of disciplines and study this complex problem. Second, we 

need to reauthorize and expand preterm activities at the CDC Division of Reproductive Health to improve national vital statistics and 

increase community-based intervention programs, to impact on 

perinatal health disparities, and third, we need to reestablish the 

federal interagency coordinating counsel on prematurity and low 

birth weight to coordinate federal efforts and keep Congress apprised of progress on the issue of prematurity prevention. 

Finally, we hope that one of the outcomes of this hearing is that 

you will agree to work with us to draft and obtain swift enactment 

of legislation reauthorizing and expanding upon the progress made 

as a result of the PREEMIE Act, and I am sure that each of you 

in the room join of all at the March of Dimes who look forward to 


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the day when every baby will be born healthy and stay healthy. 

Thank you very much. 

[The prepared statement of Dr. Fleischman follows:] 


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Written Testimony 

Alan R. Fleischman, M.D. 

Senior Vice President and Medical Director, March of Dimes Foundation 

Before the 

Committee on Energy and Commerce, Subcommittee on Health 

United States House of Representatives 

"Prematurity and Infant Mortality: What Happens When Babies Are Born Too Early" 

May 12,2010 

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today to discuss with you the public health crisis of premature birth. On 

behalf of the 3 million volunteers and 1400 staff members of the March of Dimes, I want to 

thank Chairman Pallone, Ranking Member Shimkus, and all of the other Subcommittee 

Members who are interested in working on reducing the rates of pre term birth and infant 

mortality. 

As you know, the March of Dimes is a national voluntary health agency founded in 1938 by 

President Franklin D. Roosevelt to support research and services related to polio. Today, the 

Foundation works to improve the health of women, infants and children by preventing birth 

defects, premature birth and infant mortality through research, community services, education 

and advocacy. The March of Dimes is a unique partnership of scientists, clinicians, parents, 

members of the business community and other volunteers affiliated with 51 chapters and 213 

divisions in every state, the District of Columbia and Puerto Rico. Additionally, in 1998, March 

of Dimes established its Global Programs to extend its mission overseas through partnerships 

with countries to deliver interventions directed at reducing birth defects and preterm birth. 

Building upon our experience with population based initiatives, in 2003 the March of Dimes 

officially launched a National Prematurity Campaign to address the growing, costly and serious 

problem of infants who are born before 37 completed weeks gestation. Working with our 

partners in the private sector, the U.S. Congress and two Administrations, we are beginning to 

make tangible progress. In 2006, we worked with Representative Eshoo and many other 

members of this Subcommittee to gain enactment of the PREEMIE Act (P.L. 109-450). Among 

the results of the PREEMIE Act were the 2008 Surgeon General's Conference on Preterm Birth 

and expanded research activities at the Ccnters for Disease Control and Prevention (CDC). 

The most notable accomplishment is a slight-3 percent-----<lecline in the preterm birth rate from 

2007 to 20081 (see Addendum A). But there is still much work to be done. We must build on 

progress to date and use both public and private efforts to accelerate this decrease in the rate of 

preterm birth. More than half a million will be born preterm this year and some 28,000 babies 

will die before they turn I-year 01d.2 The incidence of pre term birth represents a giant disconnect 

between our scientific knowledge and our capacity to meet basic and critical needs in maternal1 Brady E. Hamilton, Joyce A. Martin and Stephanie 1. Ventural."Births: Preliminary Data for 2008," National Vital Statistics 

Reports 58:16 (ApriI20IO): 5. 

2 T.J. Mathews and Marian F. MacDorman. '"Infant Mortality Statistics from the 2006 Period Linked Birth/Infant Death Data," 

National Vital Statistics Reports 58:17 (April 2010): 5. 

1 
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child health. According to CDC, babies who died from preterm birth-related causes accounted 

for more than 36 percent of infant deaths in 2006.3 For newborns, prematurity is the leading 

cause of death. 

Causes 

Decades of research funded by the National Institutes of Health, the March of Dimes and others 

have resulted in better care and outcomes for the sickest and smallest preterm babies, but primary 

prevention of prematurity remains elusive. We know that there are many factors that increase 

the risk of preterm birth. Perhaps the most important is smoking. Yet, in the United States today 

about one in five women of child bearing age smokes4

, and the incidence is far higher in many 

states. Alcohol, drug use, and chronic stress remain major risk factors for prematurity as well. 

An additional factor contributing to the high preterm birth rate is the increasing problem of 

multiple births primarily due to assisted reproductive technologies and the use of fertility drugs. 

Fertility drugs are used to stimulate a woman's ovaries to increase the maturity and production of 

eggs. This causes a high percentage of multiple births. According to a study published in the 

American Journal of Epidemiology by authors from the Centers for Disease Control and 

Prevention (CDC) and the March of Dimes,5 controlled ovarian hyperstimulation (COH) drugs 

account for four times more live births than assisted reproductive technologies (ART) such as in 

vitro fertilization. The study found that 4.6 percent of live births in 2005 resulted from fertility 

drug use a figure four times higher than the 1.2 percent of births resulting from ART. 

Approximately 88,000 babies born preterm annually are multiple births.6 About 60 percent of 

twins, more than 90 percent of triplets, and virtually all quadruplets and higher-order multiples 

are born prematurely compared to 11 percent of singleton births. In addition to the increased 

risks associated with multiple birth, studies have also suggested that even infants born singly, but 

conceived with ART, 7 are at increased risk for preterm delivery than naturally-conceived single 

births. Present practices and voluntary professional guidelines have not been sufficient to date to 

limit this problem. 

But in the last decade, with changing obstetric practices, we have recognized a new risk factor 

for preterm birth, iatrogenic prematurity caused by non-medically indicated early induction and 

cesarean delivery. A study published by the March of Dimes Perinatal Data Center found that 71 

percent of all preterm births fall into the "late pretenn" category, meaning 34-36 weeks 

gestation,S and that Cesarean sections account for nearly all (92 percent) ofthe increase in U.S. 

3 TJ. Mathews and Marian F. MacDonnan."Infant Mortality Statistics from the 2006 Period Linked Birth/Infant Death Data," 

National Vital Statistics Reports 58: 17 (April 2010): 11. 

4 Centers for Disease Control and Prevention. 2008 Behavioral Risk Factor Surveillance System. 

S Laura A. Schieve, Owen Devine. Coleen A. Boyle, Joann R. Petrini, and Lee Warner. "Estimation of the Contribution of NonAssisted Reproductive Technology Ovulation Stimulation Fertility Treatments to US Singleton and Multiple Births," American 

Journal of Epidemiology, 1 December 2009; 170: 1396-1407 

(, National Center for Health Statistics~ 2006 final natality data. 

7 Laura A. Schieve, Cynthia Ferre, Herbert B.Pe!crson. Maurizio Macaluso, Meredith A. Reynolds, and Victoria C. Wright. 

'''Perinatal outcome among singleton infanL'i conceived through assisted reproductive technology in the United States" Obstetr;cs 

& Gynecology: 103(6):1144-1153, June 2004. 

'DavidoffMJ. Dias T, Danms K, Russell R, Be!!egowda VR, Dolan S, Schwarz RH. Green NS. Petrini J. Changes in the 

gestational age distribution among U.S. singleton births: impact on rates of late pretenn birth, 1992 to 2002, Semin Perinatol 

2006:30(1 ):8-15. 

2 
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singleton pretenn births between 1996 and 2004.9 The rise in elective inductions and cesarean 

deliveries before tenn is the result of a number of factors: 

• Inaccurate gestational dating 

• Changing culture of obstetrical practice-more interventionist 

• Few evidence-based interventions after 34 weeks 

• Mal-aligned incentives of health care insurance/delivery systems 

• Litigious environment, defensive medicine 

• Elective inductions/c-sections for convenience-both professional and patient 

Consequences 

For those babies born pretenn that survive because of excellent care and intervention, early and 

fragile births are a major cause of devastating consequences such as a higher rate of birth defects, 

autism, learning disabilities, chronic health problems. In fact, about 25 percent of extremely 

pretenn infants are significantly and negatively affected. 1 0 

More specifically, acute consequences of prematurity include: 

• Respiratory Distress Syndrome 

• Cardiovascular Function 

• Fluid and Electrolyte Balance 

• Jaundice 

• Nutrition and Growth 

• Infection 

• Necrotizing Enterocolitis 

• Intraventricular Hemorrhage and Periventricular Leukomalacia 

While long-tenn ramifications include: 

• Chronic Respiratory Problems 

• Re-hospital ization 

• Neurodevelopmental Problems 

• Cerebral Palsy 

• Cognitive Deficits 

• Hearing and Vision Impainnent 

• Autistic Symptomatology 

The complications of being born even four to six weeks premature are also significant, since one 

third of brain growth and development occurs in the last five weeks of pregnancy (see 

Addendum 8). Late pretenn infants, born just four to six weeks early, are more likely than tenn 

infants to have significant long-term deficits such as school learning problems, disabilities, and 

lower rates of college education and lower net salaries. 1 1.12 

9 Bettegowda VR, Dias T. DavidoffMJ, Damus K, Callaghan WM, Petrini JR. The relationship between cesarean delivery and 

gestational age among US singleton births. Clin PerinatoI2008;35(2);309-23. 

10 Nicholas S. Wood, Neil Marlow. Kate Costeloe, Alan T. Gibson, and Andrew R. Wilkinson. "Neurologic and developmental 

disability after extremely preterm birth," New England Journal qfMedicine 2000;343:378-84. 

11 Steven Benjamin Morse, Hao Zheng, Yiwei Tang, and Jeffrey Roth. "Early School-Age Outcomes ofLate Preterm Infants," 

Pediatrics Apr 2009; 123: e622 - e629. 

3 
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More specifically effects may include: 

• Mortality 

• Low Apgar scores (depression at birth) 

• Respiratory distress, including respiratory failure 

• NICU admission 

• Hypoglycemia 

• Feeding problems 

• Temperature instability 

• Apnea 

• Hyperbilirubinemia (Jaundice) 

• Sudden Infant Death (SIDS) 

• Learning & behavior problems 

• Hospital readmission 

Costs 

A report issued by the Institute of Medicine in 2006 found that the annual societal economic 

costs-medical, educational, and lost productivity-associated with preterm birth were at least 

$26.2 billionl3 (see Addendum C). 

An analysis by Thomson Reuters for the March of Dimes found that in private plans offered by 

large employers, 2007 medical costs for healthy full-term babies from birth to their first birthday 

averaged $4500, of which more than $3,800 was paid by employers. For premature and/or low 

birthweight babies, the average cost was nearly $50,000, of which more than $46,000 was borne 

by the employer's health plan. Families' out of pocket expenses were substantial and 

significantly higher for premature/LBW infants. The analysis also found that, on average, 

premature infants spent more than 14 days in the hospital before their first birthday, compared to 

just over 2 days for healthy, full-term infants and that preterm babies averaged more than 21 

outpatient medical visits compared to just 14 for full-term infants. 14 

When combined, infant and maternity costs for a premature infant were four times as high as 

those for an infant born without any complications, $64,713 and $15,047 respectively, with 

employer health plans paying over 90 percent of those costs. A separate analysis showed that 

maternity care costs for complicated deliveries, independent of the infant's status and costs, were 

also significantly higher than the costs for uncomplicated deliveries: $14,667 compared to 

$10,65215 (see Addendum D). 

12 Karolina Lindstrom, Birger Winbladh. Bengt Haglund, and Anders Hjern."Prelerm Infants as Young Adults: A Swedish 

National Cohort Study," Pediatrics, Ju12007; 120: 70 - 77. 

!3 Institute of Medicine, Preterm Birth: Causes, Consequences and Prevention ,(Wa~hinbrton, DC: National Academies Press, 

2007),398. 

14 Thomson Reuters. The Cost of Prematurity and Complicated Deliveries to U.S. Employers. Report prepared for the March of 

Dimes. October 29, 2008. 

15 IBID 

4 
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In addition, Medicaid is a principal source of health insurance coverage for preterm infants. 

Approximately 48 percent of hospital stays for preterm infants were financed by Medicaid in 

2007, with hospital costs for these babies averaging $45,900.16 

March of Dimes Prematurity Campaign 

In January of2003, the March of Dimes launched its National Prematurity Campaign with the 

messages that prematurity is common, serious, and costly and having two goals: 

(1) to reduce the rate of premature birth; and 

(2) to raise awareness of the seriousness of prematurity in women of childbearing age and the 

general public. 

The Campaign has been was extended to 2020 and now includes a global component. The March 

of Dimes released the first-ever white paper on international impact of prematurity in which it 

was reported that approximately 12.9 million babies are born preterm every year (9.6 percent) 

and an estimated 28 percent of the four million annual neonatal deaths worldwide are due to 

preterm birth. 

March of Dimes Interventions 

In the last seven years, the March of Dimes has developed a multi-pronged strategy to combat 

the incidence of prematurity which includes a robust portfolio of research, education and 

programs designed to unveil the causes, comfort families in need and address risk factors and 

racial disparities. The Foundation has awarded $18 million in grants through its Prematurity 

Research Initiative to improve understanding of the etiology of pre term birth by identifying 

genetic variations that play key roles in the timing of spontaneous term and preterm delivery, 

looking for genetic differences between African-American women who gave birth preterm and 

those who did not to gain understanding in ethnic disparities in preterm birth, developing a 

medical treatment that can delay or prevent preterm labor by studying the physical properties of 

the uterine muscle, and identifying obscure and elusive bacteria and other microbes that may 

cause preterm labor. 

In direct support of families, the March of Dimes created the NICU Family Support® project. 

Currently operational in over 100 hospitals across the country, the program provides comfort and 

information to families, offers professional development to NICU staff and promotes familycentered care. An additional resource is found online at www.shareyourstory.org.This virtual 

community, along with the hospital sites, reaches more than 125,000 families each year. 

March of Dimes also provides professional educational opportunities for nurses and doctors, an 

informational Web site supplemented by social media, and a free workplace health promotion 

program for businesses called Healthy Babies I Healthy Business. This program offers education 

to women to better support healthy pregnancies and newborn care. To date, over 330 companies 

and organizations have signed on, making it available to some 20 million employees nationwide. 

16 Agency for Healthcare Research and Quality, 2009. March of Dimes HCUPnel tabulations using the 2007 Nationwide 

Inpatient sample. http://hcupnet.ahrq.gov (October 16,2009). 

5 
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The March of Dimes is also funding some innovative interventions including 

CenteringPregnancy®, a model of group prenatal care that combines assessment, health 

education, and social support. In 2009, the Foundation awarded $1.27 million in funding to 60 

programs offered in 31 states at community health centers, hospitals and public health clinics. 

This group prenatal care program has contributed to a reduction in the number of c-sections 

(from 28 percent to 21 percent), preterm births (from 8.3 percent to 1.8 percent), and lowbirthweight babies (from 8.3 percent to 2.65 percent). Centering pregnancy has also resulted in 

improved rates of breast feeding initiation, psychosocial function, and patient satisfaction. 

Three years ago, the March of Dimes launched, in collaboration with the State of Kentucky 

Department for Public Health and Johnson & Johnson, a project to address "preventable" 

preterm births in three target regions in Kentucky. The project focused on consumer awareness 

and education, health literacy in the context of prenatal care, community outreach, professional 

education, public health interventions, clinical interventions in the prenatal period, and quality 

improvement as well as safety strategies. Preliminary findings from the project show positive 

results in reducing preterm births and moderating cesarean sections. 

In 2009, the March of Dimes convened a two day Symposium on Quality Improvement to 

Prevent Prematurity where 300 of the foremost experts developed recommendations for future 

research, policy development and professional action. The Symposium recommendations 

included: treating prematurity as a public health problem to which quality improvement 

strategies can be applied, considering medical, social and environmental contexts; improving 

national and state vital statistics data collection; developing more evidence-based interventions 

with a better science base; creating universal access to high quality health care throughout the 

life cycle; adopting a systems approach to sustain improvement; understanding medical culture 

and changing it where necessary by educating the public and professionals; and engaging 

employers and insurers in prevention efforts. 

Examples of Other Effective Interventions 

In recent years, the NICHD has made a m'!ior commitment to increasing our understanding of 

the factors that result in premature birth and to developing strategies to prolong pregnancy. One 

clinical trial reported a promising preventive intervention for recurrence of preterm birth that 

relies on a derivative of the hormone progesterone. The incidence of pre term labor and delivery 

among women who had a previous preterm birth was reduced by over 30 percent in subjects 

receiving weekly injections of the compound (17P) compared to the women who were given a 

placebo. A 2005 study to examine the potential impact of this new therapy found nearly 10,000 

preterm births could have been prevented in 2002 if all pregnant women at high risk for a 

premature baby and eligible for weekly injections of a derivative of the hormone progesterone 

had received them. 17 This drug is currently awaiting approval by the Food and Drug 

Administration. 

Preconception care also continues to improve birth outcomes by addressing the singular and 

combined factors that affect them - smoking, insufficient folic acid, alcohol consumption, 

17 Joann R Petrini, William M, Callaghan, Mark Klebanoff, Nancy S. Green, Eve M< Lackritz, Jennifer 1. Howse, Richard H. Schwarz, and 

Karla Damus" "Estimated Effect of 17 Alpha-Hydroxyprogesterone Caproate on Preterm Birth in the United States," Obstetrics & Gynecology 

105(2):267-272, February 2005. 
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mental health issues, closely spaced births, genetic risks, obesity, and chronic medical 

conditions. The American College of Obstetricians and Gynecologists recommends that 

preconception care include a thorough and systematic identification of risks, the provision of 

education to fit the individual's need, and the initiation of desired interventions J8 to affect 

positive influences on a broad spectrum of outcomes including maternal health, preterm birth, 

birth defects, developmental disabilities, and infant mortality. 

There have been several effective interventions to decrease preterm birth through comprehensive 

quality improvement strategies. Intermountain Health system in Utah initiated prospective 

review of all elective inductions and c-sections prior to 39 weeks gestation that resulted in a 

dramatic decrease in early term and late preterm births, c-sections, NICU admissions, and length 

of stay for mother and baby. J9 At Parkland Hospital in Dallas, universal access to culturally 

sensitive comprehensive perinatal services over the past 15 years that includes high quality 

evidence based care with accountability and continuous quality improvement review processes 

has resulted in the lowest rates of pre term birth among African Americans and Indigent Hispanic 

populations in the U. S.20 

Recommendations for the Subcommittee 

As significant as we believe the March of Dimes Campaign and other private sector activities to 

be, success in reducing the incidence of preterm birth and infant mortality requires an ongoing 

commitment from the federal government as well. Today's recommendations from the March of 

Dimes focus on reauthorization of the PREEMIE Act (P.L. 109-450). In addition, but outside 

the scope of this hearing, there are a number of other issues, including improved access to health 

coverage and quality of care that are essential to families coping with the risk and reality of 

preterm birth. 

In 2006, the Foundation was pleased to work Congress and the Administration to secure 

unanimous approval of the PREEMIE Act (P.L. 109-450). This initiative authorized funding to 

expand research, surveillance and a few targeted projects to investigate and prevent the causes of 

preterm birth. The authorization for these activities expires at the end of fiscal year 2011, but the 

need for support of these efforts continues. Therefore, it is imperative that Congress 

reauthorize the PREEMIE Act to support expanded research, education and 

demonstration projects whose aim is to help reduce the rates of preterm labor and delivery. 

Enumerated below are our suggestions for the reauthorization bill and are drawn from the 

recommendations of the Surgeon Gencral's Conference and the Institute of Medicine Report. 

First, a recommendation included in the 10M report and reaffirmed by participants in the 

Surgeon General's Conference, calls upon the National Institutes of Health (NIH) to establish 

traus-disciplinary research centers for prematurity. The purpose of these Centers would be 

18 American College of Obstetricians and Gynecologists. Preconceptional Care: Technical Bulletin #205, 1995; and Primary and Preventive 

Care: Periodic Assessments. Committee Opinion #246, 2000. 

19 Bryan T. Oshiro, Erick Henry. Janie Wilson. D. Ware Branch, Michael W. Varner. and B.T. Oshiro. "Decreasing elective 

deliveries before 39 weeks of gestation in an integrated health care system," Obstetrics and Gynecology 113(4):804·811. April 

2009. 

20 Kenneth J. !.eveno, Donald D. Mcintire, Steven L. Bloom. Miriam R Sibley, and Ron J. Anderson. "Decreased preterm births 

in an Inner·City Public Hospital." Obstetrics & Gynecology. 113(3):578·584, March 2009 

7 
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to enhance understanding of the etiology of pre term birth using a collaborative approach. Transdisciplinary Centers integrate the expertise of a wide range of basic and social scientists as well 

as other professionals who work collaboratively to develop and use shared conceptual 

frameworks to synthesize and extend discipline-specific theories, concepts, and methods to 

create new approaches to address complex problems like prematurity. These centers would 

focus primarily on basic and translational research and would progress logically over time to 

include the need for interventional and clinical research. To accomplish their goal, the centers 

would benefit from close association or affiliation with other NIH-funded centers focused on 

clinical trials. Finally, the March of Dimes will be asking Members of the Appropriations 

Committee to provide new funding to plan and operate these centers. 

To further the robust research agenda established by the Centers for Disease Control and 

Prevention Division of Reproductive Health, the Foundation recommends reauthorizing 

and expanding on the preterm birth portfolio, including: (I) understanding the clinical, 

biological, social, genetic and behavioral factors relating to prematurity; (2) improving national 

data to facilitate tracking the burden ofpretenn birth; (3) developing, implementing and 

evaluating novel methods for prevention to better understand the growing problem oflate 

pretenn birth; (4) causes of early pretenn birth; (5) racial and ethnic disparities and effectiveness 

of community based interventions. 

To stimulate more consistent collaboration among HHS agencies and to better target resources to 

support promising research activities conducted under the auspices of various federal agencies, 

the 2006 PREEMIE Act called for the establishment of the Interagency Coordinating Council 

(ICC) on Prematurity and Low Birthweight. Unfortunately, four years later, the ICC has yet 

to be fonnally established. Moreover, the charter for the Secretary's Advisory Committee on 

Infant Mortality expired in 2007. We encourage Members of this Subcommittee to formally 

authorize the Secretary's Advisory Committee on Infant Mortality, with specific reference 

to an ICC that has the authority to solicit advice and recommendations from nongovernmental organizations with expertise and an interest in prematurity. Activities for the 

Committee should include: 

• Development of a consensus research plan on prematurity for HHS 

• Regular reporting to the HHS Secretary and appropriate committees of Congress on 

current HHS activities relating to infant mortality, prematurity and low birth weight 

Additionally, the Foundation recommends that the Health Resources and Services 

Administration be authorized to award demonstration project grants for the purpose of 

improving the dissemination of information on prematurity to health professiouals and 

other health care providers and to the public. 

March of Dimes volunteers and staff look forward to working with Members of this Committee 

as well as with the Administration and our Prematurity Campaign Partners-the American 

College of Obstetrics and Gynecology, the American Academy of Pediatrics, and the Association 

of Women's Health, Obstetric and Neonatal Nurses-to accelerate the nation's efforts to solve 

this very serious problem. We hope you will agree to work with us to draft and obtain swift 

enactment oflegislation reauthorizing and expanding upon the progress made as a result of the 

2006 PREEMIE Act. 
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ADDENDUM 

A) Preterm birth rates by gestational age-National Center for Health Statistics 

Preterm Birth Rates by Gestational Age 

U. S., 1990,2000,2005,2006,2007*, 2008* 

14 Percent 

12 

10 

8 

6 

4 

o 

1990 2000 2005 2006 2007' 200S' 

·premlinary 

lPTB (34-36 wks, 

p; 32-33wks 

ep VlBW «32 wk.) 

Source: National Vital Statistics Reports Vol. 58, Number 16 April 2010. 

B) Late Preterm Birth and Effects on Brain Development March of Dimes Educational 

Matters 

9 
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C) Annual Societal Costs Associated with Preterm Birth Institute of Medicine 

Annual Societal Economic Costs Associated with Preterm Birth, US, 2005 

Special Education Services 

$1.1 billlon{4%) 

Maternal Delivery 

$1.9 billion (7%) 

lost Household and 

labor Market Productivity 

$5.7 billion (22%) 

Early Intervention Services 

$611 million (2%) 

\ 

Medical Care Services 

$16.9 bimon (65%) 

Total Costs = 526.2 billion 

D) The Cost of Prematurity and Complicated Deliveries to U.S. Employers Thompson 

Reuters 

.. ----------------------

10 
74 

Ms. CASTOR. [Presiding] Thank you, Dr. Fleischman. 

Dr. Mahan. 

STATEMENT OF CHARLES S. MAHAN 

Dr. MAHAN. Madam Chair and members of the committee, I finished my OB/GYN residency 45 years ago, and practiced for the 

first 20 years, and then morphed into public health and directed 

the State health department in Florida for 8 years before becoming 

dean. 

I have been asked to speak to two areas by the committee. One 

was disparities, and the other is some public health steps that we 

could take immediately and in the fairly short term to start turning this around. A lot of people have also spoken to the disparities. 

The biggest problems are in African Americans. In Florida, we 

have the most black births of any State in the union, and our 

black-white infant death ratio has gone from 1.9 to 1 to 2.6 to 1, 

and last year we woke up our Hillsboro County and Tampa and 

found that it was four times the white rate. I have put some statistics there about maternal mortality again which black women suffer much more heavily than white women, and that has already 

been mentioned. 

As far as the causes of infant mortality, there is a chart on my 

testimony that shows sort of a flow chart that shows how these 

things develop, and as Dr. Callaghan pointed out, there is a very 

complex problem. You have root causes of which health and health 

care are only two, and stress has been mentioned, economics, education, family support, crime. All of these are things that can lead 

to a problematic outcome of pregnancy. And the two biggest factors 

that enter into preterm birth are social issues and maternal health 

when the mother enters pregnancy. By people smarter than I am, 

it has been predicted that if we corrected and every African American woman got into great health and great health care without addressing those other issues, we may be able to nibble away at 30 

percent of this problem. But other countries that have passed us 

in this area have dealt with the education, the jobs and the other 

things that are important leading into this issue. 

Now, depending on where you live, this isn’t just a problem in 

the black community. I am on the board of the Frontier Nursing 

Service in Kentucky, and in Appalachia, which is mostly white, we 

have terrible pregnancy outcomes there also. We have different 

root causes. Twenty-five percent of our patients at the Frontier 

Nursing Service are addicted to prescription drugs, and there is 

very little treatment available and many providers will not accept 

people that are addicted into their practice. 

The other issues that have been studied by Dr. Michael Lu at 

UCLA and Flita Mass Jackson in Atlanta Morehouse are that black 

women are victims of what is called weathering, and that is that 

if you are a black mother that has a low birth weight baby, your 

low birth weight daughter is more likely to also produce a low birth 

weight baby and then they predict it may take three or four generations of being upper income to actually shed this weathering 

system which they think is mostly due to stress. And adding to 

that, black women have the highest rates of Cesarean of any group 

in the country. 


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Now, the second part I was asked is, what public health interventions could we do to reduce prematurity. Well, one thing you 

could do right now is pick up the phone, call CMS and tell Medicaid to stop paying for elective inductions and Cesareans at any 

stage of pregnancy, and I don’t even agree with ACOG’s recommendation of 39 weeks, and we agree that that may be arbitrary, but there is probably no reason a normal woman should ever 

be induced no matter where she is. The second thing is that in our 

studies in Florida, we find that women that are agreeing to this, 

and national studies show that generally when elective things are 

done, the doctor recommends it, the patient generally does not 

bring up the subject. In fact, national studies show that less than 

one-half of 1 percent of patients do. But they are quick to go along 

with what the doctor recommends. So we have designed some informed consent that is true informed consent showing that elective 

procedures such as elective Cesarean are hazardous to the health 

of the mother and the baby. They are not equivalent to having a 

vaginal birth. And again, these are in low-risk women. And those 

are part of the attachments you will get. Unfortunately, you don’t 

have them right now. 

Vaginal birth after Cesarean has essentially disappeared even 

though studies show that having a repeat Cesarean is slightly more 

dangerous to the mother and the baby than having a vaginal birth, 

so I would propose a new scale of payment for Medicaid that would 

be something like $2,000 for a VBAC, $1,500 for a vaginal birth 

and $1,000 for a C-section, which takes less time and effort. Those 

are immediate steps that could be taken. In the short term, I would 

say in about a year, we can encourage the development of new 

pregnancy provider models. Most other countries have a midwifeand doula-based system for primary care for normal women and 

pregnancy. That can even be used for people that have high-risk 

problems comanaged with an obstetrician. Although I would recommend, and this is just coming from me, that we stop producing 

generalist OB/GYNs because as ACOG has pointed out, the young 

folks coming out today don’t want to work on nights and weekends, 

and turn it over to midwives backed up by an increased number 

of maternal fetal medicine specialists working with groups of midwives, which is a model that I have worked in in Gainesville over 

the years. It is a wonderful lifestyle and way to work. 

I also put in here pay midwives the same amount as obstetricians get paid for taking care of normal people, but it was pointed 

out to me that that is already in the new health care bill, so forget 

that one. 

I would encourage the movement to group prenatal care that 

both ACOG and other groups have recommended instead of individual prenatal care, especially for low-income women, so that they 

can do some community support of each other. 

Ms. CASTOR. Dr. Mahan, can you bring it to a close and we will 

move on? 

Dr. MAHAN. Pardon? 

Ms. CASTOR. Can you bring to a—— 

Dr. MAHAN. Yes. I think develop quality standards, provide preconception, interconception care, and then I have an extensive sesVerDate Mar 15 2010 02:39 Feb 16, 2013 Jkt 076576 PO 00000 Frm 00081 Fmt 6633 Sfmt 6633 E:\HR\OC\A576.XXX A576

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sion on the cost savings that this could have, which would be to 

the tune of about $50 billion. 

[The prepared statement of Dr. Mahan follows:] 


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Testimony 

of 

Charles S. Mahan, MD, FACOG 

DISPARITIES: 

The most serious disparities in pregnancy outcomes in the U.S. occur in African-Americans. 

Black babies in the U.S. have always been twice as likely to die before their first birthday as 

white babies but in the last decade these figures have gotten far worse in many states. (Appendix Al In 

Florida the black/white infant death ratio has gone from 1.9/1.0 in 1970 to 2.6/1.0 in 2005. Last year in 

Hillsborough County (Tampa) the black infant death rate was 4x that of whites. 

Maternal mortality among black women is a serious concern also: 

Maternal Mortality - u.s. 

Total: 8/100,000 13.3/100,000 

Black 20/100,000 33/100,000 

White 6/100,000 9.5/100,000 

(u.s. goal for 2010 = 4.3/100,000) 

Florida has the highest number of black babies born in the U.S. at 56,904 in 2006. (Appendix B) 

Many factors enter into causing infant deaths as depicted in the chart below: 

Causes of Infant Mortality 

Root Intermediate Immediate 

Causes Causes Causes 

I Social 

Issues ,. Preterml 

"" LBW Malamal ",L.-C=--"\--_ ~~l r--- Mortality 

Perinatal ,..1 Surviv,,-/ 

~v,ironment 

L~re 

r\~ 

~ 

Heallh 
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Problems with root causes are often more severe in poor black communities in the U.S. 

However poor white women are often impacted by a different set of root causes, for instance, whites in 

Appalachia have huge issues with prescription drug abuse with 25% of our pregnant women cared for by 

the Frontier Nursing Service in Kentucky addicted to oxycodone or similar drugs. The resources to deal 

with addiction in pregnancy are scarce all over the U.s. and many obstetricians refuse to care for 

substance abusing pregnant women. 

More recent studies of the difficult issue of black infant mortality in the u.s. point to an 

intergenerational effect - black mothers who themselves were prematurely born are more likely to have 

premature babies. This effect, called "weathering" by obstetrician Michael Liu at UCLA, seems to defy 

health care intervention, being so deep-seated in social problems as root causes. Because of this, if the 

u.s. somehow manages to perfect the delivery of health and health care to black families, it is estimated 

that, at most, that would impact 30% of the prematurity problem. Adding elective cesareans to the mix 

(black women in the U.S. have had the highest cesarean rates of any group for over 10 years) only 

compounds the problem. (Appendix C) 
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PUBLIC HEALTH INTERVENTIONS TO REDUCE PREMATURITY 

IMMEDIATE STEPS: 

1. Medicaid - stop paying for elective inductions and elective cesareans at iill'l stage of 

pregnancy - even 39 weeks and above. 

2. INFORMED CONSENT - Insist that true informed consent be given to pregnant 

patients at the beginning of the third trimester to be read and discussed at least 8 

weeks before the due date. These should especially highlight the dangers of 

elective induction and cesarean to the lli!Qy. (Appendix 01, D2) 

3. Vaginal Birth After Cesarean (VBAC): Put tiered financial incentives for providers in 

insurance programs to encourage VBAC since babies are healthier after VBAC than 

repeat cesarean. (Appendix E) 

SHORT TERM (1 YEAR): 

Proposed scale: VBAC - $2,000 

Vaginal birth - $1,500 

C-section - $1,000 

4. Encourage new pregnancy provider models: 

Midwives and doulas do basic primary care on all pregnant women and comanage high risk women with maternal-fetal medicine speCialists. 

(Appendix F, G, H) 

Pay midwives full amount paid to obstetricians for managing normal 

pregnancy. (Equal pay for equal work.) 

• Encourage change to group prenatal care (from individual visits). 

• Stop funding the training of generalist OB/GYN's and invest in the training of 

maternal-fetal medicine specialists to back up groups of midwives. 

Move away from hospital birth to out-of-hospital birth centers except for 

high-risk women. (Appendix I, J) 

5. Quality Standards: 

MCH Bureau (HRSA), AHRQ, CMS and CDC work with MOD and provider 

organizations (ACOG, ACNM, AAP, APHA, etc.) to outline quality standards for 

perinatal care and encourage states to use them to build their own state perinatal 

quality improvement initiatives. (Ohio, California, North Carolina and Florida have 

already begun this process.) This should include a list of procedures Medicaid will 

pay for (medical or OB high risk) and those they will not pay for (elective 

procedures). (Appendix K, L) 

6. Preconception and Interconception Care: 

Building on the excellent work of the CDC and MOD the past four years, Medicaid 

and private insurance companies should develop a panel of pre-pregnancy 
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Conclusion: 

interventions (diabetes & HIV testing, folic acid Rx, etc.) that providers can use to be 

sure the woman and her family are ready for a pregnancy and then advertise so that 

pre-pregnancy visits become as routine as prenatal care itself. 

In the interconception period all women should receive a pregnancy spacing 

method of their choice and the provider should be paid a fair price for this service. 

(Not happening now in some states' Medicaid waivers.) Women with chronic 

diseases (diabetes, hypertension) should be followed closely between pregnancies 

and not just dropped by insurance after the post-partum visit as they are now in 

many parts of the country. 

7. COST SAVINGS: 

Pregnancy is the number one diagnosis for hospital admissions in the U.s. and 

cesarean is the number one operation performed. 

Maternal and newborn charges - U.s. 

2005 -$79B 

2006 - $86B 

More than $2.5B was spent on unnecessary cesareans. Eliminating elective 

inductions and cesareans would also save hundreds of millions of dollars in 

unnecessary NICU admissions but untold amounts in the long term expenses of 

late preterm birth (special education, etc.) due to lack of brain development. 

(Appendix M, N, 0, P) 

Elective induction and cesarean and the resulting late preterm births are serious public health 

problems in the U.S. - and quickly preventable. (Appendix PP) 

Charles S. Mahan, MD, FACOG 

Dean and Professor Emeritus 

Lawton and Rhea Chiles Center for Healthy Mothers 

and Healthy Babies 

University of South Florida, College of Public Health 

Department of Community and Family Health 

3111 E. Fletcher Avenue 

Tampa, FL 33617 

Cell: 813-394-0726 

Home: 813-988-1259 

E-mail: csmahan@health.usf.edu 

Addendum: DeClercq numbers analysis (appendices Q -+FF) 
81 

Ms. CASTOR. Thank you very much. 

Dr. Lawrence. 

STATEMENT OF HAL LAWRENCE 

Dr. LAWRENCE. Thank you, Representative Castor and Chairman 

Pallone and the distinguished members of the subcommittee. My 

name is Dr. Hal Lawrence and I am an obstetrician/gynecologist 

and ACOG’s vice president of practice activities. I am here today 

representing 53,000 physicians and partners in women’s health 

care. 

Preterm birth is one of the most complicated and difficult issues 

in obstetrics. As a Nation, we still don’t know very much about the 

risk factors, the causes or prevention of preterm labor. We do know 

that preterm labor is the most common cause of hospitalization before birth, that there is a link between preterm birth and infant 

mortality, that the rate of preterm births is a growing public health 

problem that cuts across social, racial, ethnic and economic groups 

and that our Nation must do better. 

ACOG firmly believes that we can make a difference and we are 

committed to leading the change and we are very clear that deliveries before 39 weeks’ gestation should only occur when an accepted medical maternal or fetal indication for delivery exists. We have 

been intimately involved in a number of efforts over the years to 

improve research and practice guidelines to reduce the rate of premature births in America. 

ACOG is the nationally recognized source for clinical guidelines 

and medical information that help shape maternity care based on 

evidence-based peer-reviewed science and some expert opinion. 

These include practical information on late preterm births, management of preterm labor, assessment of risk factors for preterm 

birth, use of progesterone to reduce preterm birth and obesity in 

pregnancy. But where research has not been conducted, clinical 

guidelines have to wait. Preterm birth can occur in any pregnancy 

and our current clinical tools cannot determine a woman’s risk except for women, as you have already heard, who have had previous 

preterm births, the only clear risk factor. Even so, the ability to 

predict whether a woman is at risk of preterm delivery has value 

only if an intervention is available to reduce or eliminate that risk, 

and right now we have very few effective interventions. Better research can be translated into more complete clinical guidelines and 

better care. 

ACOG has been intimately involved in a number of other efforts 

to advance our knowledge in this area including the 2006 Institute 

of Medicine report on preterm birth, the surgeon general’s 2008 

conference on the prevention of preterm birth, and the 2009 Symposium on Quality Improvement to Prevent Prematurity that we 

did with the March of Dimes. These efforts identified gaps in clinical knowledge and research, many of which ACOG in our MOMS 

Initiative, and that stands for Making Obstetrics and Maternity 

Safer, called on Congress to support, and those include NIH research to reduce preterm births and the focus on obesity, CDC’s 

surveillance and research to assist State maternity mortality reviews, modernized State birth and death record systems, and improve the safe motherhood program, the HRSA fetal and infant 


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82 

mortality review, which brings together local OB/GYNs and health 

departments to reduce infant mortality rates and improve the maternal child health block grant, comparative effectiveness research 

into preterm birth interventions and efficacy, disparities research, 

testing the obstetric medical home to address the unique issues of 

pregnancy and supporting quality improvement measures. 

It is also impossible not to also mention the link medical liability 

and the practice of obstetrics performing deliveries. In the world of 

childbirth, a perfect pregnancy can turn disastrous in a heartbeat, 

and through no fault or malpractice of the obstetrician/gynecologist. 

Vaginal births after Cesarean sections, VBACs, can seem perfectly 

normal until something goes wrong. At that moment, one and 

sometimes two lives can be on the line and seconds count. It is 

often in these scenarios that OB/GYNs get sued and result in very 

large awards regardless of the physician’s care. The risk is really 

that great. ACOG recommends exploring medical liability alternatives including early offer programs, health care courts, alternative dispute resolution and birth injury compensation funds, and 

I would like to thank Representatives Pitts and Gingrey for your 

attention to this important issue in your earlier comments. 

I would also like to thank Representative Burgess, who plans to 

introduce a bipartisan piece of legislation extremely relevant to today’s hearing. His legislation will provide for research on birth defects and breast feeding to help educate women on ways to reduce 

the risk to their babies and have healthy pregnancies. Once introduced, I urge the subcommittee to quickly take up this legislation. 

I would also like to thank Chairman Pallone. ACOG has been 

fortunate to be able to work with his staff and thank him for his 

focus on stillbirth and sudden infant death, and we look forward 

to offering support as that legislation goes forward. 

Again, I would like to thank you for this opportunity to provide 

this statement. A written statement of my comments has been supplied, and we applaud your commitment and leadership on this 

issue. We look forward to working closely with you and the subcommittee. Thank you. 

[The prepared statement of Dr. Lawrence follows:] 


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ACOG 

THE AMERICAN CONGRESS 

OF OBSTETRICIANS 

AND GYNECOLOGISTS 

Testimony of 

Dr. Hal C. Lawrence, III, M.D., F.A.C.O.G. 

Vice President, Practice Activities 

American Congress of Obstetricians and Gynecologists 

Prematurity and Infant Mortality: What Happens When Babies Are Born Too Early? 

Before the House Committee on Energy and Commerce 

Subcommittee on Health 
84 


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Thank you, Chairman Pallone, for holding today's important hearing and inviting testimony from 

the American Congress of Obstetricians and Gynecologists (ACOG). My name is Dr. Hal 

Lawrence. I am an obstetrician-gynecologist and ACOG's Vice President of Practice Activities. 

I am here today representing 53,000 physicians and partners in women's health care and it is my 

pleasure to offer this statement to the House Committee on Energy and Commerce, 

Subcommittee on Health on the issues of prematurity and infant mortality. 

With the passage of health reform. this is a very good time to examine what more we can do to 

reduce prematurity and infant mortality rates in the U.S. We look forward to working closely 

with you, Mr. Chairman, and Members of the Subcommittee on a variety of measures to get us to 

that goal. 

Preterm birth is the leading cause of neonatal mortality in the United States, and accounts for 

approximately 35% of all U.S. health care spending for infants and 10% for children. According 

to preliminary 2008 NCHS data, over half a million babies were born preterm representing 

12.3% of all live births occur before term in the United States. About two-thirds of all infant 

deaths are among preterm infants. Slightly more than one-third of which are officially 

designated preterm-related, i.e., there is sufficient information recorded to ascribe being born 

preterm as the fundamental contributor to death. 

Preterm birth is one of the most complicated and difficult issues in obstetrics. As a Nation. wc 

still don't know very much about the causes of pre term labor. We do know, though, that the rate 

of preterm births in the United States is a growing public health problem that cuts across social, 

racial, ethnic, and economic groups. We know that preterm labor is the most common cause of 

antenatal (before birth) hospitalization. And we know that there is a link between preterm birth 

and infant mortality. 

Unique among all health events, infant death is always viewed as a measure of a community's 

social and economic well-being, as well as its health. It is also a measure of the organization and 

capability of a community's health services and community resources. Often infant deaths leave 

families and communities with few answers, asking: "Can anything be done to prevent this in the 

future?" 

ACOG firmly believes that the answer is a resounding yes, we can make a difference in the 

future. ACOG will continue its long history of leadership and collaboration with other 

stakeholders to make this happen. 

This year, ACOG President Dr. Gerald F. Joseph, Jr. launched the Making Obstetrics and 

Maternity Safer (MOMS) Initiative, a multi-pronged campaign to improve maternal and infant 

outcomes by filling the glaring gaps in research and understanding. ACOG's clinical guidelines 

that help shape maternity care in America are based on evidenced-based, peer-reviewed science 

and expert opinion. Our guidelines are limited, though, to clinical areas that have been wellresearched. Where the research has not been conducted, clinical guidelines have to wait. 

Congress has a unique opportunity to fund research that will provide the underpiunings 

for our guidance for practicing ob-gyns and other maternity care providers. 

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PRETERM BIRTH 

In most pregnancies, labor starts between 37 and 42 weeks gestation. Labor before 37 weeks 

gestation is considered preterm. According to preliminary 2008 data from the National Center 

for Health Statistics (NCHS), approximately 12.3% of babies born in the United States are born 

preterm and these preterm births account for most newborn deaths. 

Growth and development in the last part of pregnancy are vital to the baby's health. In fact, the 

earlier a baby is born, the greater the chance he or she will have health problems. Babies born 

preterm tend to grow more slowly than babies born at term, and often have problems with their 

eyes, ears, breathing, and nervous system; and experience learning and behavioral problems. 

While preterm labor can occur in any pregnancy without warning, we know that some women 

are at greater risk. Obese women, women who have little or no prenatal care and those who have 

had preterm labor before are at increased risk. So are women for whom too much amniotic fluid 

is in the sac that surrounds the baby. Problems with the placenta or birth defects also increase 

the risk. Certain health factors may be linked to an increased risk for preterm birth, including 

short cervical length or maternal developmental abnormalities, which are structural abnormalities 

of the uterus. However, for many women preterm labor occurs without a known cause. 

There are medical reasons why the baby is better off being born, even if it is early, including 

maternal infection, high blood pressure, bleeding, or signs that the fetus is having problems. 

Sometimes preterm labor may be too far along to be stopped. Preterm babies may need to be 

cared for in a neonatal intensive care unit (NICU) for weeks or even months. 

Women at risk for preterm labor can help reduce their risks by refraining from smoking or 

abusing drugs. Assuring safe environments to protect women from intimate partner violence is 

also important. Healthy habits also help ensure healthy pregnancies, including eating healthy 

food, not skipping meals, and following the doctor's advice. 

ACOG'S CLINICAL GUIDELINES 

ACOG is the nationally recognized source for developing clinical guidelines and communicating 

technical and scientific information for our specialty of women's health and obstetrics and 

gynecology. In a recent membership survey, ACOG found that nearly 98% of respondents were 

aware of ACOG guidelines, and 96% of respondents reported that they had used those guidelines 

over the previous five years. Sixty-one percent responded that an ACOG publication or 

guideline changed their practice within the last two years. ACOG Practice Bulletins were ranked 

first by ACOG Fellows, followed by ACOG Committee Opinions, as the sources used most often 

to stay informed about advances in research, practice trends, and ethics in obstetrics and 

gynecology. 

ACOG issues guidelines and recommendations for obstetric-gynecologic practice in four primary 

vehicles: Committee Opinions, Practice Bulletins, Guidelines, books and reports. We develop 

our recommendations and guidelines through a rigorous peer review and approval process, 

utilizing standing committees or special task forces composed of experts in the field that 

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continually examine and update existing guidelines for clinical practice based on the most up-todate scientific and medical literature, as well as expert opinion where data are lacking. 

Representatives from many related specialty societies, voluntary organizations, and federal 

agencies also serve on our committees and work groups. 

ACOG has a number of Committee Opinions and Practice Bulletins addressing premature births, 

bulleted and summarized here. 

• Late-Preterm Births 

Late-preterm births, defined as deliveries after 34 and before 37 weeks, make up 71 % of all 

preterm births. Late-preterm infants are at higher risk of developing medical complications, 

resulting in higher rates of infant mortality, morbidity before initial hospital discharge, and 

hospital readmission in the first months oflife. Late-preterm infants are 4 times more likely 

than term infants to have at least I medical condition and 3.5 times more likely to have 2 or more 

conditions. The neonatal mortality rate (deaths among infants 0-27 days chronologie age) for 

late-preterm infants is much higher than the rate for term infants. 

ACOG is very clear tbat deliveries before 39 weeks gestation sbould occur only wben an 

accepted medical maternal or fetal indication for delivery exists. 

• Management of Pre term Labor 

It is important to recognize tbat preterm labor is not tbe only mecbanism leading to 

preterm birtb; nnmerous preterm birtbs are preceded by rupture of membranes or otber 

medical problems. In fact, 80% of women with presumptive preterm labor do not progress to 

preterm delivery. 

A physician's ability to determine the risk of pre term delivery with clinical accuracy is seriously 

hampered by the large variations in symptoms of preterm labor and the inability of our current 

clinical tools to precisely determine a woman's risk. In earlier days, when a patient had 

symptoms of pre term delivery, her doctor was likely to handle this uncertainty by recommending 

an abundance of caution, including reduced maternal activity and administering fluids with the 

aim of stopping the uterine activity. Many of these early interventions have proven to be 

ineffective. 

• Assessment of Risk Factors for Preterm Birth 

The functional changes that trigger preterm labor are largely unknown but may include decidual 

hemorrhage (abruption), mechanical factors (uterine overdistention or cervical incompetence), 

and hormonal changes, perhaps mediated by fetal or maternal stress. 

Risk factors for preterm birth include demographic characteristics, behavioral factors, and 

aspects of obstetric history. Despite the identification of a number of risk factors, attempts to 

determine the risk of pre term delivery based on historic and epidemiologic risk scoring systems 

have been unable to reliably identifY women who will give birth preterm. Tbe ability to predict 

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whether a woman is at risk of preterm delivery has value only if an intervention is available 

that is likely to improve the outcome. 

• Obesity in Pregnancy 

The prevalence of obesity in the United States has increased dramatically over the past 20 years 

to the point where, today, one third of adult women are obese. During pregnancy, obese women 

are at increased risk for several adverse outcomes, including complications related to anesthesia 

and necessary surgical procedures. Multiple studies have shown that maternal obesity and 

excessive weight gain during pregnancy are associated with large-for-gestational-age infants who 

are at increased risk for childhood obesity. 

Studies consistently report higher rates of preeclampsia, gestational diabetes, and cesarean 

delivery for failure to progress in obese women. Some studies have reported a greater rate of 

premature delivery for obese women. Operative and postoperative complications include 

increased rates of excessive blood loss, operative time greater than 2 hours, wound infection, and 

endometritis. Surgery in obese women poses anesthetic challenges, such as difficult epidural and 

spinal placement requiring multiple attempts and intraoperative respiratory events from failed or 

difficult intubation. Sleep apnea may further complicate anesthetic management and 

postoperative care for these women. 

Obese women who require cesarean delivery are more likely to have an increased incidence of 

wound breakdowns and infections. Because of the increased likelihood of complicated and 

emergency cesarean delivery, extremely obese women may require additional blood products, a 

special operating table, and extra personnel in the delivery room. The success rate of attempted 

vaginal birth after cesarean delivery is very low in extremely obese women. 

• Use of Progesterone to Reduce Preterm Birth 

Progesterone is one strategy to reduce pre-term birth. However, based on current knowledge, 

it is important to offer progesterone for pregnancy prolongation to only women with a 

documented history of a previous spontaneous birth at less than 37 weeks of gestation. 

Progesterone supplementation for the prevention of recurrent pretenn birth should be offered to 

women who are carrying only one fetus, not multiples, and who have had a prior spontaneous 

preterm birth due to spontaneous preterm labor or premature rupture of membranes. Current 

evidence does not support the routine use of progesterone in women with multiple gestations. 

Progesterone supplementation may be considered for women with an identified very short 

cervical length (less than 15 mm) but who have no other symptoms. 

ACOG's Committee on Obstetric Practice and the Society for Maternal Fetal Medicine believe 

that further studies are needed to determine if progesterone therapy can be designed to help 

prevent preterm delivery in other ways, including optimal preparation, dosage, and route of 

administration. 

CLINICAL and RESEARCH GAPS IN KNOWLEDGE IDENTIFIED 

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ACOG supported and was intricately involved in the two most recent major initiatives to 

examine the issue of pre term birth; the Institute of Medicine's (lOM) Report Preterm BirthCauses, Consequences, and Prevention and the Surgeon General's Conference on the Prevention 

of Preterm Birth 

Institute of Medicine's (lOM) Report Preterm Birth - Causes, Consequences, and Prevention 

The Institute of Medicine's (10M) 2006 Report, Preterm Birth - Causes, Consequences, and 

Prevention identifies a number of gaps in clinical knowledge. Upon review of the literature 

assessing the causes and consequences of pre term birth, the diagnosis and treatment of women at 

risk for preterm labor, and treatments for infants born preterm, the 10M proposed a research 

agenda for investigating the problem of preterm birth that is intended to help focus and direct 

research efforts. 

The priority areas developed for research include the need to: 

• Improve national data, including standardization of birth certificate reporting as advocated by 

ACOG; 

• Study the economic outcomes for infants born preterm; 

• Improve the methods of identifYing and treating women at risk for preterm labor; 

• Study the acute and the long-term outcomes for infants born preterm; 

• Study infertility treatments and institute guidelines to reduce the number of multiple 

gestations; 

• Improve the quality of care for women at risk for preterm labor and infants born preterm; 

• Investigate the impact of the health care delivery system on preterm birth; 

• Investigate the etiologies of preterm birth; 

• Study the multiple psychosocial, behavioral, and environmental risk factors associated with 

preterm birth simultaneously; and 

• Investigate racial-ethnic and socioeconomic disparities in the rates of preterm birth. 

Surgeon General's Conference on the Prevention of Pre term Birth 

To address the serious and seemingly intractable problem of pre term birth, the Surgeon General's 

2008 Conference on the Prevention of Pre term Birth convened many of the country's experts 

from the public and private sectors of research, public health, and health care delivery to discuss 

preventive strategies. 

With the support and participation of ACOG, the Conference adopted the following 

recommendations: 

• Biomedical Research - A better understanding of the basic mechanisms underlying its 

etiology must be established, including the role of such factors as infection, inflammation, 

abnormal implantation and placentation, and gene-environment interactions. 

• Epidemiological Research - Epidemiologic research must address the heterogeneity of 

preterm birth and identifY methods to characterize preterm births according to underlying 

causes. 

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• Psychosocial and Behavioral Considerations - Research on the effects of race, racism, and 

social injustice for African Americans must be a priority as they bear the highest burden of 

prematurity . 

• Professional Education and Training - The education and training qfprofessionals on preterm 

birth should be comprehensive, targeted to the discipline, incorporate the social determinants 

of health, and provide skills enabling them to educate the public and patients. 

• Public Communication and Outreach - Several potential audiences should be made aware of 

the most recent research findings on preterm birth, including women of reproductive age and 

their families, health care providers, medicallhealth institutions, and both government and 

nongovernment policymakers. 

• Quality of Care and Health Services - The care and treatment of women before and during 

pregnancy should be equitable, individualized, and consistent across populations. Health care 

systems and practitioners should implement practices that are known to be effective and 

should collect data about the quality of patient care and services provided. 

Specific Knowledge Gaps Identified by ACOG 

In consideration of the broad recommendations from 10M, the Surgeon General's Report, and 

the apparent knowledge gaps evidenced in ACOG's clinical material, below are important 

specific gaps that could be addressed with additional research investments. 

• Improved assessment tools are needed to address the large variations in symptoms of preterm 

labor and the inability of routine clinical tools to precisely determine a woman's risk; 

• Evidenced-based research on interventions to delay or prevent preterm delivery; 

• Comparison studies of the effectiveness of different drugs used to prevent or slow preterm 

labor and birth; 

• Studies to evaluate the optimal preparation, dosage, route of administration, and other 

indications for the use of progesterone to prevent preterm delivery; 

• Studies on the association of multiple gestations, i.e. twins, to the risk of pre term delivery; 

• Studies on bacterial infections that have been associated with preterm labor to better 

understand if their effect and nature of association; 

• Research and interventions to address the increased risk for poor outcomes in obese women; 

and 

• Research into the disproportionately higher rate of pre term birth among African American 

women that cannot be accounted for by known risk factors. 

ACOG'S MAKING OBSTETRICS AND MATERNITY SAFER (MOMS) INITIATIVE 

Due the magnitude of the problem, it is essential that we address the issue in a comprehensive 

manner. We must make well-informed and targeted investments to help lower the rate of 

prematurity, and remember that the health of every baby starts with the health of its mother. For 

this reason, ACOG developed our MOMS Initiative, a legislative proposal to improve maternal 

and infant health outcomes through: 

• Maternal/infant health research at the NIH to reduce the prevalence of premature births and 

to focus on obesity research, treatment, and prevention; 

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• MaternaVinfant health research and surveillance at the CDC to assist states in setting up 

maternal mortality reviews; modernize state birth and death records systems to the 

2003-recommended guidelines; and improve the Safe Motherhood Program to better 

understand maternal deaths; 

• Maternal/infant health programs at HRSA to continue the Fetal and Infant Mortality Review 

(FIMR) which brings together local ob-gyns and health departments to solve a community's 

problems related to infant mortality; and improve the Maternal Child Health Block grant, the 

only federal program that exclusively focus on improving the health of mothers and children; 

• Comparative effectiveness research into interventions for preterm birth; 

• Disparities research into maternal outcomes, preterm birth and pregnancy-related depression; 

• The development, testing and implementation of quality improvement measures and 

initiatives; 

• The testing of an obstetric medical home model. 

• Maternal Mortality Reviews 

National data on maternal mortality is inconsistent and incomplete due to the lack of 

standardized reporting definitions and mechanisms. To capture the accurate number of maternal 

deaths and plan effective interventions, maternal mortality should be addressed through multiple, 

complementary strategies. CDC should fund states to implement maternal mortality reviews that 

would allow them to conduct regular reviews of all maternal deaths within the state to identifY 

causes, factors in the communities, and strategies to address the issues. Maternal mortality 

reviews are now conducted in only 15 to 20 states. Combined with adoption of the 

recommended birth and death certificates in all states and territories, CDC could collect uniform 

data to calculate an accurate national maternal mortality rate. Results of maternal mortality 

reviews will inform research needed to identifY evidence based interventions addressing causes 

and factors of maternal mortality and morbidity. 

• Electronic Birth and Death Records 

Currently, only 75 percent of states and territories use the standardized 2003 birth certificates 

and 65 percent have adopted the 2003 death certificate. The National Vital Statistics System 

(NVSS) needs federal support to help states and territories implement the 2003 birth certificate 

and modernizing their infrastructure to collect these data electronically to expand the scope and 

quality of data collected on a national basis. NVSS will need $3 million to phase in the 2003 

death certificate and electronic death records in all states and territories. CDC should work with 

the Centers for Medicare and Medicaid Services and the Office of the National Coordinator to 

pilot test the integration of electronic birth and death records and electronic medical records. 

• National Fetal Infant Mortality Review 

Since 1990, the Maternal Child Health Bureau has worked in cooperative agreement with ACOG 

to run the National Fetal Infant Mortality Review (NFIMR) program. NFIMR provides training 

and assistance to enhance cooperative partnerships among local community health professionals, 

public health officers. community advocates and consumers to reduce infant mortality. The goal 

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is to improve local services and resources for women, infants and families, to remove barriers to 

care, and to ensure culturally appropriate, family friendly services. 

These efforts are crucial to understanding and addressing infant health disparities in communities 

at highest risk and are a component of many existing Healthy Start Initiatives. A rigorous 

national evaluation ofFIMR conducted by Johns Hopkins University concluded that FIMR is an 

effective perinatal initiative. The Bureau should continue to use Healthy Start funds to support 

the NFIMR project and encourage all Healthy Start Programs to implement FIMR. 

• Obesity Research, Treatment and Prevention 

Obese pregnant women are at increased risk for poor maternal and neonatal outcomes. 

Additional research and interventions are needed to address the increased risk for poor outcomes 

in obese women receiving infertility treatment, the increased incidence of birth defects and 

stillbirths in obese pregnant women, ways to optimize outcomes for obese women who become 

pregnant after bariatric surgery, and their babies' increased risk of childhood obesity. 

• Comparative Effectiveness Research into Preterm Birth and Pregnancy-Related 

Depression 

Support for AHRQ's comparative effectiveness research initiatives is needed in order to better 

understand the range of interventions for preterm labor, such as different drugs and preventive 

tools in diverse patient populations. Research evaluating the efficacy of perinatal/postpartum 

screening tools and whether they can impact the outcome of pregnancy and perinatal depression 

is also needed. 

• Health Disparities Research in Women 

Women of racial and ethnic minorities face higher rates of diseases including obesity, cancer, 

diabetes, heart disease, and HIV / AIDS. There is also a disproportionately higher rate of preterm 

births among African American women that cannot be accounted for by known risk factors. 

HHS should conduct research into the causes of health disparities and develop and evaluate 

interventions to address these causes. Also, the continued and expanded collection of data 

capturing racial and ethnic information is essential in understanding and eliminating disparities. 

• Safe Motherhood/Infant Health 

Late-preterm births make up 71 % of all preterm births. Funding should be directed to CDC to 

improve national data systems to track preterm birth rates and expand research that focuses on 

the causes and prevention of preterm births. 

• Preterm Birth Research 

According to preliminary NCHS data, over half a million babies were born preterm in 2008, 

representing 12.3% of live births. NICHD needs increased funding to expand its support of 

preterm birth research. Congress should help explore the feasibility of establishing integrated 

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research centers at NIH as recommended by the Institute of Medicine and the Surgeon General's 

Conference on the Prevention of Pre term Birth. Specifically, NICHD needs additional financial 

support for planning activities related to the establishment of Trans disciplinary Research Centers 

for Prematurity. 

• Qualitv Improvement Measures and Initiatives 

ACOG urges Congress and the Administration to support these efforts and assist in the 

dissemination and voluntary adoption of quality measures in both the Medicare and Medicaid 

programs. ACOG is currently engaged through the PCPI in development of maternity care 

quality measures. The PCPI process is the gold standard for national development, testing, and 

maintenance of scientific evidence-based clinical performance measures at the 

physician/clinician/group level, balanced with stakeholder engagement, public comment, and 

transparency and spearheaded by clinician ownership, accountability and professionalism. We 

look forward to maintaining and improving current measures, developing new clinical measures 

in other facets of obstetrical and gynecologic care and expanding national data collection and 

aggregation initiatives on all aspects of women's health care through both voluntary data registry 

participation for physicians and facilities and mandatory certification and accreditation programs 

like American Board of Obstetrics and Gynecology Maintenance of Certification and The Joint 

Commission. 

• Obstetric Medical Home Model 

The testing ofa women's medical home, with particular attention to maternity care, is an 

important opportunity to facilitate the improvement of health outcomes in the United States and 

reduce duplicate and inappropriate utilization of services. Medical homes are rooted in the 

principle that care coordination, increasing health care access, patient-provider communication, 

and collaborative care are fundamental to improving patients' health. This delivery model has 

the potential to address the unique issues that arise during pregnancy and may be able to address 

troubling health disparities in certain populations of pregnant women. CMS should test a model 

in the Medicaid program, which finances approximately 42% of the nation's births. 

OTHER ISSUES OF IMPORTANCE 

Elective Inductions 

In more than 22% of all pregnant women in the U. S. labor is induced, and the overall labor 

induction rate has more than doubled since 1990 to 225 per 1,000 live births in 2006. The goal 

of induction oflabor is to achieve vaginal delivery by stimulating uterine contractions before the 

spontaneous onset of labor. Induction has merit when the benefits of expeditious delivery 

outweigh the risks of continuing the pregnancy. The benefits oflabor induction must always be 

weighed against the potential maternal and fetal risks associated with this procedure. 

ACOG stipUlates that unless a medical indication exists, labor induction or a scheduled 

elective delivery should not be done before 39 weeks of pregnancy. Indications for induction 

of labor are not absolute, but should take into account maternal and fetal conditions, gestational 

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age, cervical status, and other factors. Following are examples of maternal or fetal conditions 

that may be indications for induction oflabor: 

Abruptio placentae; 

Isoimmunization, i.e. Rh disease; 

Chorioamnionitis; 

Fetal demise; 

Gestational hypertension; 

Preeclampsia, eclampsia; 

Premature rupture of membranes; 

Postterm pregnancy; 

Maternal medical conditions (eg, diahetes mellitus, renal disease, chronic pulmonary disease, 

or chronic hypertension); and 

Fetal compromise (eg, severe fetal growth restriction or a deficiency in amniotic fluid.) 

Labor also may be induced if the patient is at risk for very rapid labor, if she lives an unsafe long 

distance from the hospital, or if she has serious mental health indications. Even in these 

circumstances, at least one of the established gestational age criteria should be met or fetal lung 

maturity should be established. A mature fetal lung test result before 39 weeks of gestation, in 

the absence of appropriate clinical circumstances, is not an indication for delivery. 

The individual patient and clinical situation must always be considered in determining when 

induction oflabor is indicated. 

Maternal Caesarean Delivery Request 

Cesarean delivery on maternal request is defined as a primary cesarean delivery requested by the 

patient in the absence of any medical or obstetric indication. ACOG is clear that cesarean 

delivery on maternal reqnest should not be performed before gestational age of 39 weeks 

has been accurately determined unless there is documentation of lung maturity. Cesarean 

delivery on maternal request should not be motivated by the unavailability of effective pain 

management. 

Cesarean delivery on maternal request is not recommended for women desiring several children, 

given that the risks of placenta previa, abnormal placental adherence, and the need for 

hysterectomy increase with each cesarean delivery. Other risks include a longer maternal 

hospital stay, an increased risk of respiratory problems for the baby, and greater complications in 

subsequent pregnancies, including uterine rupture and placental implantation problems. 

Literature on elective cesarean delivery without labor shows that the risk of respiratory 

morbidity, including transient rapid breathing of the newborn, respiratory distress syndrome, and 

persistent pulmonary hypertension, is higher for elective cesarean delivery compared with 

vaginal delivery when delivery is earlier than 39-40 weeks of gestation. Because of these 

potential complications, cesarean delivery on maternal request should not be performed before 

gestational age of 39 weeks has been accurately determined unless there is documentation of 

lung maturity. 

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Babies can benefit, too, by medically indicated planned cesarean delivery. Benefits can include 

lower fetal mortality; lower newborn infection rate; reduced risk of intracranial hemorrhage 

diagnosis, neonatal asphyxia, and encephalopathy; and fewer birth injuries. 

Further research is needed to get direct evidence for better counseling for women in the future. 

This includes surveys on cesarean delivery on maternal request, modification of birth certificates 

and Current Procedural Terminology coding to facilitate tracking, prospective cohort studies, 

database studies, and studies of modifiable risk factors for cesarean delivery on maternal request 

versus planned vaginal delivery. Short-term and long-term maternal and neonatal outcomes as 

well as cost need further study. 

ACOG's Task Force on Cesarean Deliverv Rates 

In 1995, ACOG held a focus session to determine ways to reduce cesarean delivery rates. This 

focus session led to the appointment in 1997 of ACOG's Task Force on Cesarean Delivery 

Rates, which was convened to assess the factors that contribute to the cesarean delivery rate in 

the United States, review ways to reduce these rates, and develop guidance material for our 

members and other concerned institutions. 

The Task Force was charged with assisting institutions and individual practitioners assess and, if 

appropriate, reduce their cesarean delivery rates. The Task Force developed the report entitled 

the Evaluation of Cesarean Delivery. 

The factors that have contributed to the increased cesarean delivery rate in the United States over 

the last 25 years are not completely understood. The report showed a wide variation in cesarean 

delivery rates between practitioners, hospitals, and geographic regions of the United States, and 

between patient characteristics including payer type, socioeconomic status, ethnicity, and 

education. Aspects of physician practice, including solo versus group practice, employment 

status, in-house coverage, and education, also appear to be associated with variations in cesarean 

delivery rates. 

From this research, it appears that the most dramatic increase in primary cesarean delivery rates 

was found in patients in their first pregnancy, with normal term single fetuses and with vertex 

presentations. It was not apparent, though, that higher cesarean delivery rates in these lower-risk 

patients result in improved outcomes. Accordingly, it would seem appropriate to focus on these 

patients when evaluating strategies for lowering the primary cesarean delivery rate. 

Although cesarean delivery rate analysis may help obstetric institutions and practitioners adjust 

their practice patterns, cesarean delivery rates alone are not an indicator of quality. All 

practitioners have some patients in their practices who are at increased risk for needing to be 

delivered by cesarean, regardless of management practices. Therefore, unadjusted cesarean 

delivery rates cannot be used to assess the quality or appropriateness of individual institutions or 

obstetric practitioners. Cesarean delivery rates must be adjusted for case mix to have any value. 

The following variables should be examined when cesarean deliveries are performed: 

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• Cervical dilatation was less than 4 cm; 

• In the presence of intact membranes; 

• Without appropriate use of oxytocin; 

• After the patient has received an epidural when cervical dilatation was.less than 4 c; 

• After the patient has undergone elective induction of labor at less than 41 weeks of gestation; 

• Without trial of labor for suspected macrosomia in nondiabetic women; 

• For failed induction of labor for suspected macrosomia in nondiabetic women; 

• For the sole indication oftwin gestation; and 

• For the indication of term fetuses with breech presentations, without offering external 

cephalic version. 

Medical Liability 

When addressing the issue of delivery rates, it is impossible to not also mention the medical 

liability problem that disproportionately targets obstetricians. Our Nation provides exceptional 

medical education, training some of the world's finest obstetricians and gynecologists. Yet, 90% 

of ACOG Fellows report they have been sued at least once. On average, ob-gyns are sued 2.7 

times during their careers, and nearly 63% have made changes to their practice during the last 

three years because of the high risk ofliability claims. 35% have either decreased the number of 

high-risk obstetric patients treated or have ceased providing obstetric care altogether; 29.1 % 

reported increasing the number of cesarean deliveries; and 25.9% indicated they stopped 

performing or offering VBACs due to professional liability concerns. 

In the world of childbirth, a "perfect" pregnancy can tum disastrous in a heartbeat, and through 

no fault or malpractice of the ob-gyn. Vaginal births after c-sections can seem perfectly normal 

until something goes wrong. At that moment, one and maybe two lives can be on the line and 

seconds count. It's often in these scenarios that ob-gyns get sued and result in very large awards, 

regardless of the physician'S care. The risk is really that great. 

A recent study conducted by staff from the Harvard School of Public Health and the Harvard 

Medical School for the Medicare Payment Advisory Commission showed caps on non-economic 

damages to be predictive of lower rates of cesarean delivery. Additionally, one study found that 

states with pretrial screening panels had significantly lower rates of cesarean delivery and higher 

rates of vaginal birth after cesarean delivery. Finally, another study of obstetrical practice found 

that joint-and-severalliability reform led to decreased use of cesarean delivery and induction or 

stimulation of labor. 

ACOG has for many years advocated reform of our broken medical liability system, including 

caps on non-economic damages, and other reforms like those found in Texas and California. We 

will continue to fight for those reforms on behalf of our specialty and our members. At the same 

time, we strongly support alternatives, including sorry works programs and health courts, that 

can help reduce the need for defensive medicine and improve patient safety. 

ACOG highly recommends exploring ways to reduce rates of caesarean delivery through state 

and federal experimentation on medical liability reform. We urge Congress to assist states foster 

meaningful alternatives to current medical tort litigation that improve patient safety and quality 

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of care, provide fair and prompt compensation for medically-related injuries, restore fairness and 

reliability to the medical justice system, and reduce defensive medicine. These alternatives can 

include early offer programs, healthcare courts, voluntary alternative dispute resolution, and birth 

injury compensation funds. 

RECOMMENDATIONS 

ACOG's MOMS Initiative 

ACOG strongly urges Congress to implement the MOMS Initiative to develop and apply 

evidence-based interventions, and improve maternal and infant health outcomes through funding 

research to: 

• Reduce the prevalence of premature births; 

• Focus on obesity research, treatment, and prevention. 

• Assist states in setting up maternal mortality reviews; 

• Modernize state birth and death records systems to the 2003-recommended guidelines; 

• Improve the Safe Motherhood Program to better study pregnancy-related deaths. 

• Continue the Fetal and Infant Mortality Review (FIMR); 

• Improve the Maternal Child Health Block grant; 

• Carry-out comparative effectiveness research into interventions for pretenn birth; 

• Perfonn disparities research into maternal outcomes, preterm birth and pregnancy-related 

depression; 

• Test the obstetric medical home model 

• Support quality improvement measures and initiatives 

Institute of Medicine's (10M) Report Preterm Birth - Causes, Consequences, and 

Prevention 

ACOG supports the Institute of Medicine's (10M) 2006 Report, Pretenn Birth Causes, 

Consequences, and Prevention report. The 10M proposed a research agenda for investigating the 

problem of pretenn birth and is an essential guide for focusing and directing research efforts to: 

• Improve national data; 

• Study the economic outcomes for infants born pretenn; 

• Improve the methods of identifYing and treating women at risk for pretenn labor; 

• Study the acute and the long-term outcomes for infants born preterm; 

• Study infertility treatments and institute guidelines to reduce the number of multiple 

gestations; 

• Improve the quality of care for women at risk for pretenn labor and infants born preterm; 

• Investigate the impact of the health care delivery system on pretenn birth; 

• Investigate the etiologies of pretenn birth; 

• Study the multiple psychosocial, behavioral, and environmental risk factors associated with 

preterm birth simultaneously; and 

• Investigate racial-ethnic and socioeconomic disparities in the rates of pretenn birth. 

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Surgeon General's Conference on the Prevention of Pre term Birth 

ACOO supports the implementation of the following recommendations adopted by the 

Conference: 

• Biomedical Research 

• Epidemiological Research 

• Psychosocial and Behavioral Considerations 

• Professional Education and Training 

• Public Communication and Outreach 

• Quality of Care and Health Services 

PREEMIE Act Reauthorization 

ACOO is proud of its support of the 2006 passage of the Prematurity Research Expansion and 

Education for Mothers who deliver Infants Early (PREEMIE) Act. This legislation was passed 

unanimously by the House and Senate and signed into law to help identify the causes of 

prematurity and reduce the episodes of pre term labor and delivery. 

With the reauthorization of the PREEMIE Act nearing, ACOO strongly urges Congress to 

swiftly take up the issue and we look forward to working with you to perfect the reauthorization 

language. 

Medical Liabilitv 

ACOO highly recommends exploring ways to reduce rates of caesarean delivery through state 

and federal experimentation of medical liability reform alternatives. These efforts should 

include as early offer programs, healthcare courts, voluntary alternative dispute resolution, and 

birth injury compensation funds, as well as caps on non-economic damages and other reforms 

like those found in Texas and California law. 

Thank you again for the opportunity to provide this statement to the House Committee on 

Energy and Commerce, Subcommittee on Health on the issues of prematurity and infant 

mortality. We applaud your commitment and leadership on this issue, Chairman Pallone, and 

look forward to working closely with you and the Subcommittee. 

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Appendix 

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ACOG 

Tl!EAMERICAN CONGRESS 

Of OBSTETRICIANS 

.AND GYNECOLOGISTS 

May 2010 

The American Congress of Obstetricians and Gynecologists' (ACOG's) 

Making Obstetrics and Maternity Safer (MOMS) Initiative 

Pregnancy and childbirth is a joyous and safe experience for the majority of mothers in the 

United States, and ob~gyns play the leading role in delivering this care. Yet the US lags behind 

other industrialized nations in healthy births, and we know very little about why. While the 

recently enacted health care reform law will expand access to prenatal care - an essential 

component to improving birth outcomes - research is critically needed to understand how we can 

drive down our maternal and infant mortality and prematurity rates. Effective research based on 

comprehensive data is a key to developing, testing and implementing evidence-based 

interventions 

ACOG is committed to leading this improvement as part of our imperative to make motherhood 

as safe as possible. Congress and the federal government have important roles to play by helping 

fund major research initiatives to help us understand the links and effective strategies to help 

ensure safe births and healthy babies. ACOG's MOMS Initiative is a multi-pronged approach 

that will help the U.S. develop and implement evidence-based interventions to improve maternal 

health. 

1) Understand the Causes, Improve Interventions for, and Reduce the Prevalence of 

Premature Births. 

2) Focus on Obesity Research, Treatment, and Prevention. 

3) Improve Snrveillance and Data Collection On Maternal and Infant Health. 

4) Support MaternallInfant Health Programs at HRSA. 

5) Research Disparities in Maternal Care, to Eliminate Disparities. 

6) Develop, Test and Implement Quality Improvemeut Measures and Initiatives. 

7) Test an Obstetric Medical Home Model 

1) Understand the Causes, Improve Interventions for, and Reduce the Prevalence of 

Premature Births. 

Between 1990 and 2006, the U.S. experienced a 20% increase in the number of premature births. 

While in 2008 we saw a 3% decrease in preterm births, preliminary 2008 data from the National 

Center for Health Statistics (NCHS) show that preterm births still account for 12.3% of all births. 

In many cases the causes are unknown. Both the Centers for Disease Control (CDC) and the 

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National Institutes of Health' s National Institute for Child Health and Human Development 

(NICHD) must expand existing research and evaluation of the factors behind these numbers, 

using improved national data systems to ensure consistent reliable statistics on preterm birth 

rates and expanding research into the causes and prevention of preterm birth. 

NICHD's research activities may be augmented through integrated transdisciplinary research 

centers, as recommended by the Institute of Medicine and the Surgeon General's Conference on 

the Prevention of Pre term Birth. Patient-centered outcomes research, also known as comparative 

effectiveness research, should focus on evaluating the efficacy of interventions in different 

sUbpopulations for preterm labor, including differcnt drugs and preventive efforts. 

2) Focus on Obesity Research, Treatment, and Prevention. 

Obese pregnant women are at increased risk for poor maternal and neonatal outcomes, and the 

prevalence of obesity in the United States has increased dramatically over the past 20 years. The 

most recent National Health and Nutrition Examination Survey (NHANES) for 1999-2002 

found that approximately one third of adult women are obese. This problem is greatest among 

non-Hispanic black women (49%) compared with Mexican-American women (38%) and nonHispanic white women (31 %). 

Several studies have consistently reported higher rates of preeclampsia, gestational diabetes, and 

cesarean delivery, particularly for failure to progress, in obese women than in non-obese women. 

Additional research and interventions are needed to address the increased risk for poor outcomes 

in obese women receiving infertility treatment, the increased incidence of birth defects and 

stillbirths in obese pregnant women, ways to optimize outcome in obese women who become 

pregnant after bariatric surgery, and the increased risk of childhood obesity for their babies. 

3) Improve Surveillance and Data Collection Efforts On Maternal and Infant Health. 

• Modernize state birth and death records systems to comply with the 2003-recommended 

guidelines. 

Only 75% of states and territories use the 2003 birth certificates and 65% have adopted the 2003 

death certificate. Additional funding must be provided to NeIlS' National Vital Statistics 

System (NVSS) to support states and territories in implementing the 2003 birth certificate and 

modernizing their infrastructure to collect these data electronically to expand the scope and 

quality of data collected. Funding to support the phasing in of the 2003 death certificate and 

electronic death records in states and territories must also be made available. CDC should also 

work with the Centers for Medicare and Medicaid Services (CMS) and the Office of the National 

Coordinator to pilot-test the integration of electronic birth and death records and electronic 

medical records. 

• Assist states in setting up maternal mortality reviews. 

National data on maternal mortality is inconsistent and incomplete due to the lack of 

standardized reporting definitions and mechanisms. To capture the accurate number of maternal 

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deaths and plan effective interventions, maternal mortality should be addressed through multiple, 

complementary strategies. The CDC should provide funds to states for implementation of 

maternal mortality reviews that conduct regular reviews of all deaths within the state to identifY 

causes, factors in the communities, and strategies to address the issues. Combined with adoption 

of the recommended birth and death certificates in all states and territories, CDC could then 

collect uniform data to calculate an accurate national maternal mortality rate. Results of 

maternal mortality reviews will infonn research needed to identify evidence based interventions 

addressing causes and factors of maternal mortality and morbidity. Only 15 to 20 states operate 

maternal mortality reviews today. 

Improve the CDC Safe Motherhood Program to study pregnancy-related deaths. 

To better understand maternal complications and mortality and to decrease disparities among 

populations at risk of death and complications from pregnancy, the CDC's Division of 

Reproductive Health's Safe Motherhood Program supports national and state-based surveillance 

systems to monitor trends and investigate health issues; conducts epidemiologic, behavioral, 

demographic, and health services research; and works with partners to translate research findings 

into health care practice, public health policy, and health promotion strategies. 

One such program is the Pregnancy Risk Assessment Monitoring System (PRAMS). PRAMS 

was initiated in 1987 because infant mortality rates were no longer declining as rapidly as they 

had in prior years, and the incidence oflow birth weight infants had not significantly improved 

in the previous 20 years. Research indicates that maternal behaviors during pregnancy may 

influence infant birth weight and mortality rates. The goal of the PRAMS project is to improve 

the health of mothers and infants by reducing adverse outcomes such as low birth weight, infant 

mortality and morbidity, and maternal morbidity. PRAMS provides state-specific data for 

planning and assessing health programs and for describing maternal experiences that may 

contribute to maternal and infant health. Currently 37 States participate in the PRAMS; this 

program should be expanded to all States. 

• Develop a Maternity CAHPS. 

Understanding the experience and perspective of mothers is paramount in improving the delivery 

of maternity care. The Consumer Assessment of Healtheare Providers and Systems (CAHPS) 

program developed through the Agency for Healthcare Research and Quality (AHRQ) is the gold 

standard for patient experience surveys at the health plan, hospital, and clinician levels. Survey 

topics cover the communication skills of providers (important for shared decision making and 

infonned consent) and the accessibility of services. Currently, the CAHPS Consortium has 

products that cover dental care, primary care, and newly released in 2009, surgical care. ACOG 

urges AHRQ to fund the deVelopment of maternity CAHPS in 2010. 

4) Support MaternallInfant Health Programs at HRSA 

• Continue support of and expand the Fetal and Infant Mortality Review (FIMR). 

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FTMR brings local ob-gyns and health departments together to solve community problems 

related to infant mortality. Since 1990, the Maternal Child Health Bureau has worked in 

cooperative agreement with ACOG to run the National Fetal Infant Mortality Review (NFIMR) 

program. NFIMR provides training and assistance to enhance cooperative partnerships among 

local community health professionals. public health officers, community advocates and 

consumers to reduce infant mortality. The goal is to improve local services and resources for 

women, infants and families, to remove barriers to care, and to ensure culturally appropriate, 

family friendly services. Such efforts are crucial to understanding and addressing infant health 

disparities in communities at highest risk and are a component of many existing Healthy Start 

Initiatives. A rigorous national evaluation ofFIMR conducted by Johns Hopkins University 

concluded that FIMR is an effective perinatal initiative. 

• Improve funding for the Maternal Child Health Block Grant. 

The MCHB Grant is the only federal program that exclusively focuses on improving the health 

of mothers and children by ensuring access to quality care, especially for those with low-incomes 

or limited availability of care. 

5) Perform Disparities Research into Maternal Outcomes. 

Women of racial and ethnic minorities face higher rates of diseases including obesity, cancer, 

diabetes, heart disease, and HIV/AIDS, when compared with white women. There is also a 

disproportionately higher rate of pre-term birth among African American women that cannot be 

accounted for by known risk factors. HHS must support research into the causes of health 

disparities and develop and evaluate interventions to address these causes. Continued and 

expanded c.ollection of data capturing racial and ethnic information is essential in understanding 

and reducing disparities. 

6) Develop, Test and Implement Quality Improvement Measures and Initiatives. 

The American College of Obstetricians and Gynecologists is an active leader in the national 

quality measurement arena. We have a standing executive committee seat 

on the American Medical Association (AMA)-convened Physician Consortium for Performance 

Improvemcnt ® (PCPI) and arc active members of the National Quality Forum, AQA (formerly 

Ambulatory Care Quality Alliance), and the Surgical Quality Alliance (SQA). ACOG is 

currently engaged through the PCPI in development of maternity care quality measures. 

The PCPI process is the gold standard for national development, testing, and maintenance of 

scientific evidence-based clinical performance measures at the physician/clinician/group 

level, balanced with stakeholder engagement, public comment, and transparency and 

spearheaded by clinician ownership, accountability and professionalism. We look forward 

to maintaining and improving current measures, developing new clinical measures in other facets 

of obstetrical and gynecologic care and expanding national data collection and aggregation 

initiatives on all aspects of women's health care through both voluntary data registry 

participation for physicians and facilities and mandatory certification and accreditation programs 

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like American Board of Obstetrics and Gynecology Maintenance of Certification and The Joint 

Commission. 

ACOG urges Congress and the Administration to support these efforts and assist in the 

dissemination and voluntary adoption of quality measures in both the Medicare and Medicaid 

programs. 

7) Test an Obstetric Medical Home Model 

The testing of a women's medical home, with particular attention to maternity care, is an 

important opportunity to facilitate the improvement of health outcomes in the United States and 

reduce duplicate and inappropriate utilization of services. Medical homes are rooted in the 

principle that care coordination, increasing health care access, patient-provider communication, 

and collaborative care are fundamental to improving patients' health. This delivery model has 

the potential to address the unique issues that arise during pregnancy and may be able to address 

troubling health disparities in certain populations of pregnant women. CMS should test a model 

in the Medicaid program, which finances approximately 42% of the nation's births. 

ACOG looks forward to partnering with Congress and the Administration on the MOMS 

Initiative to improve maternity outcomes for women and babies. For more infonnation please 

contact Nevena Minor, Manager, Government Affairs at nminor@acog.org or 202-314-2322. 

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Ms. CASTOR. Thank you, gentlemen. Your testimony was outstanding. 

Let me start by asking about a subject that you each very briefly 

touched on, and that is the inaccurate gestational dating. It seems 

like there is a concern out there about if the recommendation is 

you go fully to term at 39, 40 weeks, how do you really measure, 

especially in certain subgroups, that you have an accurate due 

date, and then how do we—is it the same based on socioeconomic 

factors and education or is there something a little more concrete 

that we can get? I would like to hear from all of you on that. 

Dr. LAWRENCE. Thank you for that question. Obviously whenever 

you have any recommendations on timing of delivery, having accurate dates of that pregnancy is crucial, and we have published 

guidelines on how you determine when somebody is at least 39 

weeks’ gestation, and those guidelines clearly state that you have 

to have had an ultrasound at least in the early second trimester 

to confirm an estimated date of confinement, or due date, so you 

are sure they are 39 weeks, or you have to have had 36 weeks of 

pregnancy following a serum or urine pregnancy test, or you had 

to be able to have documented fetal heart tones for 30 weeks since 

they were first documented. All three of those methodologies will 

confirm that somebody is at least at 39 weeks’ gestation. I know 

that there is discussion about earlier first-trimester scanning. We 

think that that is an interesting opportunity also. We have discussed this several times and Dr. Fleischman and I have discussed 

this several times. I know in Great Britain they do something 

called a booking scan. But when our committees look at this and 

carefully weigh the benefit and the costs of those ultrasounds at 

that 16-, 18-, 19-week gestation, not only do you get a very accurate gestational age calibration plus or minus seven to nine days, 

you also get a good anatomy evaluation of that fetus. So there is 

a whole lot more benefit found and so because of that our committees have been unable to say we should recommend two scans at 

this point in time. 

Dr. MAHAN. We had talked about this before we testified, but the 

39 weeks that ACOG recommends, I think we should look at that 

again in the college because if a woman is entirely normal, why 

should you even have the 39-week recommendation? You know, 

Mother Nature tells you when term is because labor starts, and the 

Institute for Health Care Improvement basically recommends that 

we wait for labor to begin and see how labor goes, again in normal 

people. You certainly have to count on all the things Dr. Lawrence 

said for somebody who is high risk if you are going to have to deliver them early. 

Dr. FLEISCHMAN. We go back to the Institute to Medicine report 

in 2006 that clearly recommended early ultrasounds in the first trimester as the most accurate gestational dating, which would, I 

think, give us combined with history a very important public 

health program in order to assure that the kinds of complex things 

that Dr. Lawrence is saying are the appropriate ways if you don’t 

have the earliest ultrasounds. I think if we did that as almost 

every obstetrician in American has in their office, the ultrasound 

machine, at the earliest times to find the fetal viability as well as 

the fetal gestational age, we would be making better decisions at 


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the end of pregnancy. We know time and time again from intervention studies that if you put off at least until 39 weeks, and I am 

not disagreeing with Dr. Mahan, but at least until 39 weeks you 

run a very low risk of prematurity, and if you don’t have accurate 

gestational dating you increase the risk of premature birth. 

Ms. CASTOR. Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Madam Chair. I concur with you. It is 

great testimony. One thing I really enjoy about this subcommittee 

on health care, it is a caring profession. I mean, everybody is doing 

it for the right reason, whether it is adults, and this one of course 

on the unborn children. So with all our fights and battles, it is really great to have people who are very concerned. 

Dr. Mahan, I really enjoyed your testimony. I have questions for 

you. I am an old Army infantry guy, and you know, we just keep 

it simple, and it seems like your testimony kind of keeps it simple. 

God has created phenomenal human beings—not your words, mine. 

The body tells us when. We shouldn’t be doing things that aren’t 

natural unless we have to, I think if I could summarize. And then 

there is ways to incentivize that financially because we are a big 

payer. We are a third payer in a lot of the health care delivery system. And so why not use that tool? We did miss that opportunity, 

but then maybe there are other opportunities to relook at that. I 

really enjoyed the testimony. 

Dr. Fleischman, you state that there are several factors that 

have caused the increase in elective inductions, that is kind of leading on this debate, and Cesarean deliveries. You do mention in 

your statement about the litigious environment and defensive medicine. Can you talk about that? I am from Illinois. We have had a 

huge medical liability crisis. We had a Supreme Court campaign 

turn on this, and even though that was the primary reason because 

all our physicians were leaving the State, it wasn’t enough and 

then we have gone back to that. So I know we don’t like to talk 

about it, but it is in your statement. Talk about that for me, will 

you? 

Dr. FLEISCHMAN. Well, we are very sympathetic to the obstetric 

practitioners concerning their concerns and fears about the litigious 

environment. We believe the best way to prevent lawsuits is to 

have the highest quality care, to set standards, to set guidelines 

and to practice appropriately with appropriate accountability. That 

protects both the patient and the doctor, and I think we are moving 

in those directions. We have the national quality forum and the 

joint commission and others setting standards. We have CMS now 

to set standards around perinatal health and quality measures. We 

think that high-quality practice is the way for the obstetric community to assure that they are actually able to protect themselves and 

their patient. 

Mr. SHIMKUS. And I appreciate that, but how do you tie that in 

to the litigious—I get it. I mean, if we don’t have problems, then 

you don’t have lawsuits, but how do you tie that in to the courtroom drama that unfolds? Is it making sure—I have been through 

this for years now as far as the public policy guys, make people 

that say I am sorry. I mean, how do you tie that to the courtroom? 

That is the issue? 

Dr. FLEISCHMAN. Well, I think—— 


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Mr. SHIMKUS. I mean, your words. I am not putting—you talked 

about the litigious environment and defensive medicine. 

Dr. FLEISCHMAN. Well, we can stand up tall if we practice highquality medicine based on ACOG guidelines and appropriate care, 

and if we do that, then even if we make our way to the courtroom, 

we can have a reasonable defense of good high-quality practice and 

decrease the incentives on the part of those who are bringing those 

lawsuits—— 

Mr. SHIMKUS. But you are not willing to talk about the courtroom dilemma that they still face regardless of this. 

Dr. Lawrence, do you want to weigh in on medical liability? 

Dr. LAWRENCE. Thank you very much. Medical liability is just a 

huge issue in our practice, and you all have heard this, I am sure, 

before, but, you know, over 90 percent of practicing obstetrician/ 

gynecologists have been sued, and I would tell you 90 percent of 

anybody isn’t doing bad things, and I think each of you know that. 

Mr. SHIMKUS. I always usually say in any organization, you may 

have 10 percent who are bad actors. Unfortunately, we find that 

here. I found that in the military. You find that in schools. I would 

agree, 90 percent—— 

Dr. LAWRENCE. But not 90 percent. 

Mr. SHIMKUS. I would have to agree, 90 percent, there is something else going on. 

Dr. LAWRENCE. And the thrust of your question, you know, 

ACOG works hard to put forth guidelines enabling medical staffs 

and local community hospitals to create practice parameters and 

protocols to help take care of these patients. The problem for us is 

that even when you do all that, even when you do it all right, that 

does not guarantee a perfect outcome. Reproduction has never been 

perfect. Sadly, reproduction will never be perfect. There will always 

be adverse events. There will always be situations that are not predictable. And somehow in this process, if the providers are doing 

everything right, we should not be held accountable for an adverse 

outcome that we could not have prevented, and that is true in the 

VBAC situation that I mentioned. It is true in many other situations in managing patients whether they are high-risk patients or 

whether they are deemed to be low risk and then all of a sudden 

there is a cord prolapse or all of a sudden there is an abruption 

or all of a sudden there is a vasa previa. I have been there. I have 

jumped in and done those deliveries. And fortunately, they usually 

go OK but not always, but if you do it right, somehow the liability 

system has to recognize that and deal with this other than within 

a tort arena. 

Mr. SHIMKUS. Madam Chair, I am not going to follow up with a 

question, but if I may just again thank you all, and I am going to 

follow up with a written question on Medicaid expansion and reimbursement rates and other things that I would like to get into but 

time is not going to allow me to do that. 

Ms. CASTOR. Thank you very much. 

Dr. Christensen. 

Mrs. CHRISTENSEN. Thank you, Madam Chair. 

Dr. Mahan, true informed consent, how do you define that and 

how do you arrive at that? 


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Dr. MAHAN. I think it needs to be based on—and I have worked 

with the National Coalition to Improve Maternity Services on this 

for the past year, especially for informed consent for Cesarean, and 

we based all of our efforts on science, evidence based, but what we 

were finding, and this is among studies of upper-income people, 

upper middle-class people, was that it was really a last-minute sort 

of glossed-over thing that this is all going to be OK. So in the attachments that you will get is a copy of the—it is called the risks 

of Cesarean section, a checklist that women should be given at 

about 32 weeks of pregnancy, not at term, so that she and her partner can go through it, look at the differences—— 

Mrs. CHRISTENSEN. Both sign? 

Dr. MAHAN. Pardon? 

Mrs. CHRISTENSEN. Are both supposed to sign it? 

Dr. MAHAN. I believe so, yes, and so is the care provider. Now, 

this is just a suggestion. It has not been adopted except by this 

particular group. But for instance, when the mother looks at the 

section possible problems for my baby, my baby is more likely to 

have breathing difficulties—this is after Cesarean—it is normally 

best for labor to begin, so on and so on and so on, and my baby 

is more likely to die than if it was born vaginally, which is not a 

high chance but it is statistically more likely to do that. The mother needs to know that. 

Mrs. CHRISTENSEN. Thank you. And your third immediate recommendation, I would ask you and Dr. Lawrence and perhaps Dr. 

Fleischman as well, what is the data on outcomes in vaginal birth 

after Cesarean, and does ACOG recommend that after the first Cesarean that women go through vaginal delivery? 

Dr. LAWRENCE. ACOG, in fact following the NIH consensus conference that we just participated in, have a new practice bulletin 

about discussing vaginal birth after Cesarean section, and in there 

we do recommend that women be offered a trial of labor after Cesarean section, assuming that that section was for a non-recurring 

cause, assuming that there wasn’t like she had—— 

Mrs. CHRISTENSEN. If it was a breech and—— 

Dr. LAWRENCE. Correct, like a breech, and we do recommend that 

those patients be counseled and offered that procedure. Institutions 

have to be able to provide the services to support that procedure, 

and the problem with VBAC is where the risk of a uterine rupture 

and spontaneous labor is low, it is less than 1 percent. If, however, 

it occurs, the same Dr. Lu that Dr. Mahan used as a reference earlier has a study from Los Angeles County that shows you have 12 

minutes to get that baby born or that baby will probably not survive, and if it does survive will be severely handicapped. So because of liability concerns, many institutions and many providers 

have said I am not willing to put that baby at that much risk. At 

that same NIH consensus conference on VBAC, one of the 

attendings from Parkland stood up and gave a scenario of a perfectly managed VBAC, everything was doing fine. In fact, this patient had delivered vaginally after her previous Cesarean section, 

which puts her in a lower risk. Everything was going great. The 

uterus ruptured, crash Cesarean section, baby delivered. Baby did 

not do well. An $11.5 million settlement against the institution and 

the physicians. And that group no longer does VBACs. So that is 


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the scenario that vaginal birth after Cesarean section has placed 

many obstetrical providers, and that is the reason that the concern 

has been raised about that procedure. 

Dr. MAHAN. And I would follow up with that, and I agree, and 

I think that was an excellent conference, but the issue that we 

have to deal with now is that, you know, I think Dr. Spong’s studies that she has helped publish have shown that VBAC is slightly 

safer for the mother and baby other than a repeat Cesarean. You 

can lose babies and mothers with a repeat Cesarean. The problem 

that we need to deal with, and it is tied up with the liability issue, 

is that since so few hospitals are providing VBAC—now, USF, we 

do do that in our practice group. Women in communities that can’t 

get it are turning to home birth because they can’t get it anywhere 

else and they had such a bad experience with their first pregnancy 

that they don’t want to go back to the hospital and we are really 

worried about that too. So it is another reason to deal with the liability crisis. 

Dr. FLEISCHMAN. I think the fundamental question, and I agree 

with these gentlemen, but the fundamental question is, how do we 

decrease primary Cesarean sections that are done unnecessarily, 

and we know that if we induce a woman when she’s not ready to 

deliver, she is highly likely to result in a Cesarean section, and 

then we put the woman in the position of, you know, the question 

of vaginal birth after Cesarean. I think that is the real challenge. 

Ms. CASTOR. Thank you very much. 

Mr. Pitts. 

Mr. PITTS. Thank you, Madam Chairman. 

Dr. Fleischman, you mentioned Institute of Medicine. The Institute of Medicine recently published a 570-page resource book entitled ‘‘Preterm Birth: Causes, Consequences and Prevention.’’ On 

pages 517 and 518, abortion is noted as an ‘‘immutable’’ risk factor. 

However, the risk factor is avoidable if women are given risk information prior to pregnancy. I would like each of you to respond to 

this, and I know of 59 studies that have found that women with 

prior induced abortions are at increased risk for premature birth 

and low birth weight. The question is two parts. Do your organizations acknowledge abortion as a risk factor, and is it included in 

your information searches? Are you aware of efforts to inform 

women about such a risk factor? Each of you, please. Dr. 

Fleischman? 

Dr. FLEISCHMAN. At the March of Dimes, we continually monitor 

those data that you have mentioned, and the most recent data from 

modern techniques in termination do not give convincing evidence 

of that as a significant risk factor for preterm birth, and we do not 

raise that issue within our materials. 

Mr. PITTS. Dr. Mahan? 

Dr. MAHAN. I don’t know the answer to that. I know that one of 

my—I just read the executive summary of that report. One of my 

problems with it was that it was a little behind the times because 

it really wasn’t dealing with the elective induction/Cesarean issue. 

But one of the things I bring out in my testimony that I hope you 

will read is that one of the key things to improved maternal health 

and infant health in the United States is interconception care and 

preconception care so that—especially interconception care of 


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109 

women who have already had a low-birth-weight baby. Right now 

essentially we just drop them and we wait to see when they are 

going to have the next pregnancy when we know that it would be 

help if we spaced their pregnancy for at least two years and so I 

think following the diabetic woman who just had a pregnancy, 

making sure she is in good shape, following the woman who had 

a low-birth-weight baby, trying to get her out there for 2 years before she gets pregnant again, if we can provide—you know, in Florida we woke up last year and the CDC told us that we are 51st 

of all the States plus D.C. in providing reversible contraception to 

women, and this is the 50th anniversary of the Pill. When the Pill 

came out and I was a student in Chicago, the average family size 

was six and a half, and now it is one and a half. If we want to reduce abortion if it does cause this problem, we have got to stop putting our heads in the sand about helping people space their pregnancies. 

Mr. PITTS. Dr. Lawrence? 

Dr. LAWRENCE. Well, I would like to have a couple points. First 

off, I am aware of the data. We do review that data. And I also 

agree with Dr. Fleischman that more recent studies with more recent technologies don’t show a real correlation between induced 

pregnancy termination and premature birth. I also think that Dr. 

Mahan is right on target here, and I think one of the benefits of 

the health care reform law is that now patients are going to be able 

to have ongoing continual care, and as Dr. Spong said earlier, the 

best way to have a healthy baby is to have a healthy mommy and 

ongoing well women’s health care rolled in with contraceptive care, 

rolled in with preconception care is a major factor in helping to reduce preterm birth and improve maternal and infant outcomes. 

Mr. PITTS. Thank you. 

Dr. Fleischman, I didn’t quite get your response. Do you believe 

comprehensive medical malpractice reform would potentially help 

providers stop practicing defensive medicine? 

Dr. FLEISCHMAN. I guess the detail of what the comprehensive 

medical malpractice reform means—— 

Mr. PITTS. Well, like they have in California or Texas. 

Dr. FLEISCHMAN. Well, we have not taken a position on that at 

the March of Dimes. 

Mr. PITTS. OK. What about you, Dr. Mahan? 

Dr. MAHAN. Absolutely. 

Mr. PITTS. And Dr. Lawrence? 

Dr. LAWRENCE. I am in total support. If we get comprehensive 

medical liability reform, it will help not only OB/GYN but all areas 

of medicine. 

Mr. PITTS. Dr. Mahan—— 

Ms. CASTOR. I am sorry. 

Mr. PITTS. Oh, I am out of time. 

Ms. CASTOR. We would like to get Dr. Burgess in before we adjourn. 

Mr. PITTS. Thank you. My time is up. 

Ms. CASTOR. Dr. Burgess. 

Mr. BURGESS. We have a series of crucial votes and the entire 

Nation hangs in the balance in 15 minutes, so we will have to take 

off and do those. I appreciate you all being here today. I appreciate 


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110 

you staying with us. Listening to your testimony, your answers to 

some of the other questions is certainly intriguing. 

Dr. Fleischman, I am going to answer Mr. Pitts’s last question 

for you. Defensive medicine is learned behavior and physicians are 

probably not likely to unlearn that behavior overnight. There may 

be—certainly it will help but when I am criticized by the President 

because we did liability reform in Texas, and McAllen, Texas, is 

still a high-cost place to get health care, you are not going to 

change it overnight even as good as our law has been in Texas. I 

don’t think there is any question—you know, Dr. Mahan, you talk 

about VBACs, and I remember the studies that came out of Los 

Angeles while I was still in practice and I think they just absolutely threw up their hands and stopped offering VBACs for a 

while because of the liability issue, and certainly, Dr. Lawrence, 

your story of what the group in Dallas got into the $11 million settlement, if we are paying $1,000 more for a VBAC but we get hit 

with an $11 million judgment, that is 11,000 VBACs we are going 

to have to do to cover the cost of that $11 million judgment, and 

as you guys know, the numbers just don’t work out. 

We do have to undertake a more sensible medical justice system 

in this country. I don’t know what it is. I like early offer but what 

is happening in Texas now with a trifurcated cap on non-economic 

damages seems to be working and it seems to be working in a big 

way and not just holding down costs of premiums for practicing 

physicians but holding down costs for institution that self-insure 

for liability, allowing smaller not-for-profit hospitals to have more 

money to invest in capital improvements, nurses’ salaries and the 

very things we want our smaller nonprofit hospitals to do in our 

communities. So I certainly stand behind what is happening in 

Texas. I would have liked to have seen us do more in the health 

care law that passed but unfortunately we didn’t do it. 

Now, Dr. Mahan, your discussion on Medicaid, you said for Medicaid to stop paying for elective inductions and elective Cesarean 

sections in any stage of pregnancy. That may be great in theory but 

we have a problem back home where you can have a hard time 

finding a doctor who will take a patient’s Medicaid because the reimbursement rates are so much lower than commercial insurance, 

and as a consequence are we likely to make it even tough for that 

woman to get prenatal care because we have now created a more 

hostile environment within the Medicaid system. The practicing 

physician is going to look at it and say well, you know, maybe I 

was about to get over the funding problem but I am darn sure not 

going there when they are telling me how to practice. 

Dr. MAHAN. Well, I thought that too but we are working on the 

issue in Florida now because we did study it and find an association between the rising rates of Cesarean and the rising rates of 

late preterm, and that will be published pretty soon, and we found 

that our colleagues in obstetrics around the State and they found 

this already ahead of us in North Carolina and Ohio, that they understand that this is producing bad outcomes in both women and 

babies that otherwise would have been normal, but that they 

should not be delivered by Cesarean or induced if they are normal 

people because the outcomes are worse, and I think we are finding 

that most of the OBs as we approach them on this and saying we 


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111 

are producing a lot of bad babies because of this are extremely willing to listen to that and to change their practice. And I agree that 

from State to State the Medicaid rates are a problem but, you 

know, half of our births are Medicaid and these are doctors taking 

care of them and they seem to be willing to step in and reverse this 

thing. 

Mr. BURGESS. Now, in the health care law that just passed, there 

was some protection for primary care that Medicaid rates would be 

75 percent of Medicare rates, but in your State are OB/GYNs considered primary care? 

Dr. MAHAN. I don’t think so. 

Mr. BURGESS. I don’t think so either. And of course, in the law 

we don’t know because that is all up to the Secretary of Health and 

Human Services and we are not having the types of hearings that 

would allow us to get an idea of what their thinking is over there 

so we are just all going to be surprised one day. But even then, if 

there is a funding cliff that occurs in 2 years’ time and even if we 

were to get OB/GYNs designated as primary care so that they 

would get 75 percent of the Medicare rates, that funding cliff kicks 

in in 2 years’ time and we are back to the preexisting Medicaid. 

So all this becomes terribly difficult and terribly complicated. 

I guess just one last observation. Dr. Lawrence, you referenced 

the medical home. That is what the generalist OB/GYN, at least 

when I was practicing, that is what we were, and Dr. Mahan says 

we shouldn’t have those anymore, the generalists are not helpful, 

let us go to midwives and perinatologists. But you seem to see 

value in the medical-home model, and I would just submit to you, 

the physicians of my generation, that is what we were trained to 

do. 

Dr. LAWRENCE. And I think we still train OB/GYNs to do that. 

We are the care coordinators for well women’s health care essentially from the late teenage years up until early years to years after 

menopause, and we definitely are the care coordinators and providers for obstetrical patients, and we are the ones who are able 

to intervene when those acute crises occur. 

Ms. CASTOR. Thank you, Doctor, very much. 

We are going to have to bring the hearing to a close, but I would 

like to ask Dr. Fleischman to help bring us to a close and spend 

1 minute on the implications for brain development because you 

have a terrific visual exhibit here that I am afraid they won’t be 

able to see at home, but if you could describe the difference in 

brain development from 35 weeks to 39 to 40 weeks to close us out 

for the hearing, I would appreciate it. 

Dr. FLEISCHMAN. We developed this visual for a project in Kentucky to help women understand that one-third of the growth and 

development of the brain occurs between 35 and 39 or 40 weeks, 

that all those neurons, all those nerve cells that interact with each 

other are continually growing in those last 5 weeks and that that 

growth and development is critically important to the fetus. It can 

happen outside the uterus but it happens better inside a uterus if 

the fetus is not in any jeopardy. And that has been very helpful 

both to help clinicians understand what they can stay to women 

and it helps women to not push hard for inappropriate early deliveries. 


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Ms. CASTOR. Well, thank you very much. You all have been outstanding. All of the witnesses were just terrific today. That concludes all the questioning. 

In closing, I want to remind members that you may submit additional questions for the record to be answered by the relevant witnesses. The questions should be submitted to the committee clerk 

within the next 10 days. The clerk will notify your offices of the 

procedures. 

Without objection, this meeting of the Subcommittee is adjourned. 

[Whereupon, at 5:40 p.m., the Subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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Statement of Chairman Henry A. Waxman 

Energy and Commerce Committee 

Subcommittee on Health 

Hearing on "Prematurity and Infant Mortality: What 

Happens When Babies Are Born Too Early?" 

Mr. Chairman: Thank you holding today's hearing on 

a very important, and unfortunately, not well understood, 

medical challenge - babies being born too early. 

Over the last many years, prematurity has grown to 

become, in the view of many, a significant public health 

problem. And despite the encouraging news reported by 

CDC just yesterday -- pre-term birth rates have dropped by 

4% over the past two years -- prematurity remains an 

ongoing concern. For good reason: 

• When babies are born before they are fully developed, 

they have an increased risk of dying and of lifelong 

disability . 
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• Prematurity is the single largest cause of infant 

mortality in this country. Fully 30% of babies who are 

lost in the first year of life die from prematurityrelated causes. 

• Babies who survive early birth may suffer from a 

number of acute health complications, including brain 

damage, blindness, and underdeveloped lungs. These 

babies are also at increased risk for long term 

cognitive and physical developmental delays. And it 

is now clear that these risks exist not only for babies 

born very prematurely, but also for babies born at 36 

or 37 weeks - just shy of a full term pregnancy. 

• Pre-term birth is a problem that affects all people, but 

alarming disparities persist among certain racial and 

ethnic minorities, particularly African Americans. 

African American babies are 50% more likely to be 

born early than white babies and prematurity has been 

the leading cause of death for these infants for more 

than a decade. 

2 
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• All of this -- and more -- has resulted in a world infant 

mortality ranking for the United States that is 

embarrassingly low. Whether we are in the middle of 

the pack among our sister nations or closer to the 

bottom -- an analysis we should leave to 

demographers and statisticians -- there is no doubt that 

we are not where we should and must be. 

Despite these disturbing facts, progress -- as 

underscored by CDC's findings announced yesterday -- has 

been made on a number of fronts. Perhaps best known is 

the ground-breaking work of the nation's network of 

neonatal intensive care units. These are the specialty 

sections of hospitals where highly-trained health 

professionals take care of the most fragile babies and 

infants children who would have otherwise died several 

decades ago. 

3 
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But clearly, there is still much work to do. Experts are 

starting to understand the risk factors associated with 

prematurity, but the root causes remain generally unknown. 

As well, in many cases, we don't know how to prevent 

premature labor or to stop it once it has begun. And the 

impact on a baby's health when doctor and patient 

deliberately decide on an early delivery -- through a socalled "c-section" -- is a topic of hot debate. 

These uncertainties leave no question, however, that in 

this country, too many babies are being born early, and too 

many of those are dying. I hope that today's hearing will 

help us understand how we can begin to reverse this trend 

and, in turn, improve the health of our truly most 

vulnerable people - our nation's newborns. 

I thank today's witnesses for joining us and look 

forward to their testimony. 

4 
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Statement of the Honorable Anna G. Eshoo 

Committee on Energy and Commerce, Health Subcommittee 

Hearing on "Prematurity and Infant Mortality: What Happens When Babies Are 

Born Too Early?" 

May 12,2010 

Mr. Chairman, thank you for holding this hearing on premature births and infant 

mortality. I think it's fitting that we discuss this important issue as Mother's Day was 

just celebrated. The birth of a child is a miraculous event and I know speaking from 

experience that every mother hopes for a full-term, healthy child. No mother would 

choose to have a baby born prematurely and the health risks that ensue. 

I first introduced the PREEMIE Act in 2003 with my colleague Representative Upton to 

expand and coordinate research activities on preterm labor and delivery and infant 

mortality. The legislation also directed the CDC to conduct research on the relationship 

between prematurity, birth defects, and developmental disabilities. While I'm proud to 

say that legislation was signed into law in 2006, our work in this area is not done. 

According to the CDC, more than half a million babies in the U.S.-or about I in every 

8-are born prematurely every year. Unfortunately, that number is on the rise. Between 

1990 and 2006, the preterm birth rate rose by more than 20 percent in the United States. 

While the causes for preterm births are varied, the harmful consequences to the mother 

and baby can be long-term ... and expensive. 

A March CDC report tinds that almost I in 3 births in the U.S. are now performed via Csection. Mothers who go into premature labor have a much higher likelihood of a Csection. This method of delivery involves major abdominal surgery, and is associated 

with higher rates of surgical complications, maternal re-hospitalization, and 

complications requiring neonatal intensive care unit admission. In addition to health and 

safety risks for mothers and newborns, hospital charges for a cesarean delivery are almost 

double those for a vaginal delivery, imposing significant costs. 

In 2005 alone the economic cost of preterm birth in the United States was at least $26.2 

billion, and the average first-year medical costs were approximately ten times greater for 

preterm babies, compared to full-term babies. 

These national numbers are frightening, nothing could be more frightening, and so is the 

experience of having your baby whisked away to endure medical procedures because it 

was born prematurely. I look forward to hearing from our witnesses today and learning 

more about how we can prevent dangerous preterm births. 
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Opening Statement 

Honorable Ranking Member Joe Barton 

Subcommittee on Health 

May 12,2010 

Mr. Chairman, thank you for holding this hearing on 

prematurity and infant mortality. According to the Centers 

for Disease Control (CDC), prematurity is the leading risk 

factor for infant mortality. It has often been cited that the 

US is raked 29th in the world and has among the worst 

infant mortality rates compared to other industrialized 

countries. 

While any infant death is a tragedy, I believe it is 

important that the Committee understand how mortality 

reporting requirements differ among countries. I would like 

to understand if these statistics are really comparing apples 

to apples. For example, some European countries classifY 
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live births differently. In the United States, all live births at 

any birth weight or gestational age are required to be 

reported. However, in France, only live births at either 22 

weeks of gestation or later, or at 500 grams of birth weight 

or more are required to be reported. Furthermore, there are 

differences among nations about registering a child's birth 

even at the provider and hospital level which may lead to 

underreporting of mortality data. These reporting 

variations can lead to mortality numbers that are inaccurate. 

I am pleased that the American College of 

Obstetricians and Gynecologists (ACOG) is testifYing 

today. I would like this Committee to recognize the 

importance of medical liability reform on these providers. 

The new health care law contains no real liability reform; 

instead it only provides grants to States to test alternatives 
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to civil litigation. According to a "2009 Survey on 

Professional Liability" conducted by ACOG, more than 63 

percent of ob-gyns report making changes to their practice 

due to the risk or fear of liability claims or litigation; 60% 

have made changes to their practice because liability 

insurance is either unavailable or unaffordable. Albert L. 

Strunk, ACOG deputy executive vice president is quoted as 

saymg: 

"This latest survey shows that the medical liability 

situation for ob-gyns remains a chronic crisis and 

continues to deprive women of all ages-especially 

pregnant women-of experienced ob-gyns. Women's 

health care suffers as ob-gyns further decrease 

obstetric services, reduce gynecologic procedures, and 

are forced to practice defensive medicine." 
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Medical liability reform works. If this Committee 

truly cares about reducing prematurity and infant mortality, 

then we need to ensure that there will be enough providers 

practicing in the field so that more women have healthier 

babies. 

While the issue of infant mortality is important there 

are other pressing issues this Committee has failed to 

examine. Physicians will experience a 21 percent payment 

cut in Medicare reimbursement at the end of this month, yet 

this Committee has not held a single hearing on this issue 

in the past two Congresses. 

Mr. Chairman, it is also important that Members of 

this Committee also have an opportunity to question 

Secretary Sibelius about implementation of the 3,000 page 
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health law. As each day passes, Americans are growing 

wearier as new details emerge of how this law will 

dramatically alter the delivery of health care in this country 

as it stands today. 

Finally, this is the third time that CDC is testifYing 

before this Committee since the March 2010 Subcommittee 

markup ofHR 847, the 9/11 health program bill. Mr. 

Chairman, you have expressed your desire to pass HR 847; 

however, CDC has not once corne to testifY about the 

parameters of this new entitlement program. 

Mr. Chairman, I yield back the balance of my time. 
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THE SECRETARY OF HEALTH AND HUMAN SERVICES 

WASHINGTON, O,C. Z0201 

The Honorable Nancy Pelosi 

Speaker of the 

House of Representatives 

Washington, D.C. 20515 

, May 10,2010 

The Honorable Harry Reid 

Majority Leader 

United States Senate 

Washington, D.C. 20510 

f\-rc-bJ tI-t 

({: COl)"" , 

5cN\t../du 

~i.1.fz:., 

G~or\f)"rj 

Q. i eli it::. 

The Honorable John Boehner 

Minority Leader 

The Honorable Mitch McConnell 

Minority Leader 

House of Representatives 

Washington, D.C. 20515 

United States Senate 

Washington, D.C. 20510 

Dear Speaker Pelosi, Senator Reid, Senator McConnell, and Representative Boehner: 

Just over a month ago, Congress passed and President Obama signed the Affordable Care Act. 

We wanted to provide an update on the Administration's implementation of this landmark new 

law that will give the American people control over their own health insurance by holding 

insurance companies accountable, bringing down costs, and giving Americans more insurance 

choices. 

Over the last month, the Administration, including the Departments of Health and Human 

Services, Labor, and Treasury, has worked expeditiously but carefully to implement the early 

insurance market refonns called for in the Affordable Care Act and to strengthen the health care 

system for all Americans. We have made significant progress. A brief update on our 

implementation efforts is provided below. 

Adult Child Coverage: Today, the Departments of Health and Human Services, Labor and 

Treasury issued new regulations to extend coverage to young adults by allowing them to stay on 

their parents' health care plan until age 26. Before Congress passed the Affordable Care Act, 

many health plans and issuers could - and, in fact, did - remove young adults from their parents' 

policies because of their age, leaving many college graduates and others with no insurance. 

Today, about 30 percent of young adults are uninsured, representing more than one in five of the 

uninsured Americans. This rate is higher than for any other age group. The Affordable Care Act 

and the regulations announced today will help close the coverage gap for young Americans. 

While the new provision takes effect for policies and plan years beginning on or after September 

23, 20ID, more than 65 insurance companies have voluntarily agreed to provide coverage to 

young adults before the deadline. On April 27, the Internal Revenue Service released new 

guidance specifically stating that children can be covered tax-free on their parents' health 

insurance policies. According to analysis by the Department of Health and Human Services of 

this provision, adding young adult coverage would increase average family premiurnsby an 

average of 0.7 percent, while allowing 1.2 million young Americans coverage under their 

parents' plans through employcrs or the individual market. 
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May 10,2010 

Page 2 

Pre-existing Conditions: Effective for policies or plan years beginn,ing on or after September 23, 

the Affordable Care Act will prohibit health insurers from excluding coverage of children 

becauSe of pre-existing conditions. We will soon be issuing regulations to implement that 

important policy. When questions were raised about whether insurers would work to avoid 

covering children with pre-existing conditions, we called on the nation's health insurance 

companies to provide coverage to these vulnerable Americans. On March 29, health insurance 

companies agreed to ensure that children with pre-existing c.onditions were not denied coverage. 

Adults with pre-existing conditions also suffer under the old industry rules that allowed 

insurance companies to carve out needed benefits, charge sky-high rates or deny coverage 

altogether. In 45 states across the countrY, insurance companies can discriminate against people 

based on their pre-existing conditions when they trY to purchase health insurance directly from 

insurance companies in the individual insurance market. In 2014, discrimination based on preexisting conditions will be banned under the Affordable Care Act. In the meantime, a new 

transitional high-risk pool program was included to help provide affordable health insurance 

coverage to people Vl>110 are uninsUred because of pre-existing conditions. TIns high-risk pool 

program will operate until health insurance exchanges are implemented in 2014. States may 

choose whether and how they participate in the program, which is funded entirely by the federal 

government. If states choose not to run the program, hidividuals can apply for insurance from a 

federal fallback high-risk pool. The program begins on July 1, 2010. 

Over the course of the last month, the Administration has engaged in significant outreach to 

determine the needs of states in implementing the program. As.ofMay 3, 30 states hav-c 

indicated that they \vant to operate their own transitional high-risk pools, while 18 have said they 

would prefer a federal fallback high-risk pool for eligible citizens in their state. For those that 

wish to run a state-based program, applications were sent today, May·1 0, to expedite the 

implementation. To ensure states can obtain ali the i.nformation they need to establish this 

program, a working session will be scheduled in the near future to give states an opportunity to 

ask questions and receive technical assistance directly from our subject matter experts. 

Early Retiree Reinsurance Program: On M"lY 4, the Department of Health and Human Services 

issued a regulation implementing the $5 billion early retiree reinsurance program, which will be 

launched on June 1,2010, several weeks ahead of the June 21 start date required by law. We 

worked closely with large employers, early retirees, and other interested parties in developing 

this regulation. The Business Round Table released a positive statement in support of the 

program. Participating employment-based plans will receive reimbursement for a portion of the 

costs of certain medical claims associated with providing health benefits to early retirees age 55 

through 64, as well as for retirees' spouses and dependents. The amount of this payment to the 

plan sponsor is 80 percent of the costs attributable to that claim, provided the amount of the 

claim is between $15,000 and $90,000. Both self-funded and insured plans may apply, including 

plans sponsored by private entities, state and local governments, nonprofits, religious entities, 

unions, and other employers. 
125 


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May 10,2010 

Page 3 

Rescissions: Effective for policies or plan years beginning on or after September 23, the 

Affordable Care Act prohibits some of the worst insurance company practices, including the 

practice of rescinding coverage from policyholders when they become sick and need it most. We 

are pleased that the insurance industry announced they will immediately follow the new rules 

rather than wait for the new law to make it illegal and we wiU watch closely to ensure they keep 

their word. 

Small Bnsiness: The Affordable Care Act provides tax credits to small employers who purchase 

health insurance for employees. An estimated 4 million small businesses nationwide could 

qualifY for the tax credit, which will provide a total of $40 billion in relief for small firms over 

the next 10 years. Small businesses can take advantage of the tax credit immediately, and, last 

month, the Internal Revenue Service released guidance and began delivering postcards to the 

estimated four million small businesses and tax-exempt organizations to make them aware of the 

tax credit. 

Lowering Premiums: A new policy in the Affordable Care Act - the "medical loss ratio" -

creates new incentives for insurance companies to be more efficient, and ensures that consumer 

premiums are being used to pay for medical care rather than excessive and unnecessary 

administrative costs. The law requires large-group plans to spend 85 percent of premium doUars 

(80 percent in the small group market) on clinical services and activities that improve health care 

quality. Insurers offering coverage in the small group and individual markets must allocate at 

least 80 percent of premiums to such services and activities while those in the large group market 

must spend at least 85 percent of premiums on benefits. It also calls for the National Association 

of Insurance Commissioners (NAlC) to establish uniform definitions and methods for calculating 

medical loss ratios. While the law requires NAlC to submit such defmitions and methods for the 

Secretary's review by December 31, 2010, at our request, NAlC has agreed to accelerate 

delivery to June 1, 2010 .. 

Medicare Part D Doughnut Hole: As required by the new law, the U.S. Department of Health 

and Human Services plans to issue $250 rebate checks to Medicare beneficiaries who have 

reached the "doughnut hole" in prescription drug coverage. We expect the first checks to be 

mailed on June 15, and additional checks to be mailed roughly every six weeks thereafter until 

the end of the year. The Centers for Medicare & Medicaid Services projects four million 

beneficiaries will receive a check in 2010 - about 80,000 of them in the June 15 initial mailing, 

followed by larger mailings throughout the summer and fall. As part of our effort to ensure 

seniors can afford the prescription drugs they need, we vvil! increase efforts to prevent Medicare 

fraud and scams targeted at seniors related to the mailing of these rebate checks. 

~v.er the course of the coming weeks, our team across government will continue to work 

dihgently to produce the regulations and guidance necessary to implement this landmark new 

law, and we look forward to working with you to deliver the benefits of the Affordable Care Act 

to the American people. 
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CC The Honorable Max Baucus, Chainnan 

Senate Committee on Finance 

Kathleen Sebelius 

The Honorable Charles GrassIey, Ranking Member 

Senate Committee on Finance 

The Honorable Tom Harkin, Chairman 

Senate Committee on Health, Education, Labor and Pensious 

The Honorable Michael Enzi, Ranking Member 

Senate Committee on Health, Education, Labor and Pensions 

The Honorable Henry Waxman, Chairman 

House Committee on Energy and Commerce 

The Honorable Joe Barton, Ranking Member 

House Committee on Energy and Commerce 

The Honorable Sander Levin, Chairman 

House. Committee on Ways and Means 

The Honorable Dave Camp, Ranking Member 

House Committee on Ways and Means 

The Honorable George Miller, Chairman 

House Committee on Education and Labor 

The Honorable John Kline, Ranking Member 

House Committee on Education and Labor 

May 10, 2010 

Page 4 
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THE AMERICAN ASSOCIATION OF PRO LIFE 

OBSTETRICIANS AND GYNECOLOGISTS 

INDUCED ABORTION AND THE RISK OF SUBSEQUENT PREMATURE 

BIRTH: General comments and Summary of the pertinent literature. 

Preterm Birth has become a very significant and extremely expensive medical reality in 

the United States (and other countries as well). Premature birth (birth before 37 weeks) 

has increased 27% since1981. In 2002 the premature (preterm, or PTB) rate was 

12.1 % of all Jive births (and over 17% of all African-American births). 

In 2003, the American College of ObGyn and the March 'of Dimes foundation 

announced a major campaign to decrease the number of premature births in America 

Partnering with them in this campaign were the American Academy of Pediatrics, and 

the Association of Women's Health, Obstetrics, and Neonatal Nurses. 

This campaign has identified a number of risk factors of premature birth, including 

infection, maternal or fetal stress, , bleeding or abruption, uterine stretch, maternal age, 

weight, smoking, drug use, and genetic component. But, they conclude, "There is no 

known cause in HALF of premature births.'~ AAPLOG is very concerned that they 

fail to mention induced abortion as a risk factor. It simply does not come up on 

their radar screen (nor on their Website). Yet the existing medical literature strongly 

confirms that induced abortion may playa significant role in premature (preterm) birth 

(PTB) in a subsequent pregnancy. At least S9 studies have demonstrated a statistically 

significant iI\crease in premature birth or low birth weight risk in women with prior 

induced abortions. 

The March of Dimes failure· to mention induced abortion as a risk factor for preterm 

birth is consistent with the published position of the American College of Obstetrics and 

Gynecology. The ACOG Practice Bulletin #26 (April, 2001) states: "Long term risks 

sometimes attributed to surgical abortion include potential effects on reproductive 

function, cancer incidence, and psychologic sequelae. However, the medical literature, 

when carefully evaluated, clearly demonstrates no significant negative impact on any of 

these factors with surgical abortion." This Bulletin was replaced in Oct, 2006 with 

Practice Bulletin #67, which does not repeat this misinformation. However, neither is 

there correction of this misinformation in any ACOG literature we have seen to date. 

(Dec 2008). Consistent with this position, the ACOG Amicus Brief for the 2006 Ayotte 

US Supreme Court Case declares authoritatively: " ..... Contrary to the claims of the State 

and its amici, there is simply no reliable evidence that abortions are harmful to minors' 

health. Extensive reviews have concluded that there are no documented negative 

psychological or medical sequelae to abortion among teen-aged women. Minors who 

obtain an abortion are not at greater risk of complications in future pregnancies, future 

medical problems, or future psychological problellls." AAPLOG does not feel this 

sweeping conclusion can be justified ill the medical literature. To the contrary, there is a 
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very strong case in the medical literature implicating induced abortion as a risk factor for 

preterm birth, and as a factor in the escalating PTB rate seen over the past 30 years. 

Understand and addressing the risk factors for the preterm birth "epidemic' is crucial 

because Jow birth weight (LBW) and preterm birth (PTB) are the most iinportant risk 

factors for infant modality or later disabilities, as well as for lower cognitive abilities 

and greater behavioral problems. In addition to the huge human cost, the economic 

cost required to properly care for these premature babies is a severe challenge to medical 

~re system. 

Following are comments on several of the prominent studies focusing on the association 

between induced abortion and risk of subsequent preterm birth. 

THE THORP REVIEW 

Reference: Thorp, et. al., Long term Physical and Psychological Health Consequences 

of Induced Abortion: Review of the Evidence; (OB GYN Survey, Vo158 #1, 2002): 

12 of24 studies showed an association between Induced Abortion and PTB, showing a 

risk up to double the expected risk. Thorp identified a "DOSE RESPONSE" effect. i.e., 

the more IA. the higher the risk. 

THE CALHOUN·ROONEY REVIEW 

Calhoun, B, Rooney, B; Induced Abortion and Risk of Later Premature Birth; (Journal 

of American Physicians and Surgeons, Volt 8, #2, 2003): 

Calhoun and Rooney reported on 1993 Australian study by Lumley of 121,305 births. 

See Table I for results: 

Gestational age 

20-27 wks(XPB) 

28-31 wks 

32-36 wks 

Number of prior lAs 

1 2 3 

RR RR RR 

!:.f. M. 5.6 

1.5 1.1 2.6 

1.1 1.6 2.4 

1998 study 

4+ 

RR 

2 

Table 1: Premature birth risk by # of prior induced abortions compared with outcome of 

first pregnancies. (Lumley. "The epidemiology of Pre term birth, Baillieres "Clinical 

OBGYN, 1993:7(3)477-498). Also Lumley in Prenatal Neonatal Med 1998; 3:21-24) 

(244,000 live births) 

Most of the induced abortions reported in this study were by vacuum aspiration, which 

would be the least traumatic method for the cervix. Nevertheless, these lA's resulted in 

the significant increases in PTB. Notice that the Extreme Preterm Birth (XPB) 

category is inordinately affected. with doubling of XPB with just 2 lA's, an increase of 

over 5 times the expected rate with 3 lA's, and an astounding nine-fold increase with 4 

or more induced abortions (the latter figure from a 1998 study by Lumley. analyzing 

243,679live births.) 
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THE BAVARIAN STUDY 

Calhoun and Rooney reported on a1998 study from Bavaria of 106,345 births. See Table 

2 for results. 

Martius, et.al; "Risk factors ... " EuroJ.ObGynReproBiolI998;80: 183-189) 

Number of prior lAs 

1 2 3 or 'more 

Gestational age RR RR RR 

<32 weeks '2.5 5.2 8.0 

<37 weeks 1.5 2.1 3,6 

Note again, the dose response (more lA's produce more PTB). Note also the inordinate 

increase in Early Preterm Birth (under 32 weeks) associated with repeat induced 

abortion--an eightfold increase after 3 induced abOitions 

THE DANISH STUDY 

Calhoun and Rooney reported on 1999 Danish study, which showed that a mid trimester 

abortion by D&E, (dilatation and evacuation) increased the risk of PTB substantially. 

This seems logical, as the D&E procedure necessarily results in more cervical trauma 

than a simple suction curettage. One prior D&E more than doubled the PTB rate, and 

two prior D&E's increased the risk 12 times higher than the rate for women with no 

abortion history.(Zhou, Sorenson, Olsen, "Induced abortion and subsequent pregnancy 

duration," Obstet Gynecol1999;94:948-953) 

THE EUROPOP STUDY 

A 2004 EUROPOP Study of 17 countries (7719 patients) concluded that the risk ofvery 

preterm birth (22 to 32 weeks), compared to women with no abortion history, increased 

by 50% (1.5 times higher)after one abortion, and increased by 80%(1.8 times 

higher) after 2 abortions_ (Human Reproduction, Vol 19, No.3, 29 Jan 2004, pp. 734-

740) 

THE EPIPAGE STUDY 

Moreau C, et al."Previous induced abortions .and the risk of very preterm delivery" Br J 

OBGyn,200S; 112:430-437. 

Previous induced abortions and the risk of very preterm delivery: results of the 

EPIPAGE study. (2837 patients) Among women who had ~or more abortions, 

compared to women with no abortion history, there was a 50% increase (1.5 times 

higher) in very preterm births,(22-32 wks); two or more abortions resulted in a 160% 

increase (2.6 times higher). In this particular study they also looked at extremely 

preterm deliveries (22-27 weeks) and found a 70% increase (1.7 times higher) for those 

who had at least one prior abortion. 

THE 10M REPORT 

The most recent and complete commentary on the preterm birth question is found in the 

Institute of Medicine's newly published (National Academy of Science Press, July 06) 

S70 page resource book entitled '" Preterm Birth.' Causes, Consequences, and 
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Prevention." This report has beel1 applauded by ACOG, SART, and ASRM as an 

exceptional work on this adverse pregnancy result. ACOG is a co-sponsor of this work. 

With a careful search, one will fmd a single reference to induced abortion as a risk 

factor for Pl'eTerm Bit·th, found in the Appendix, on page 517-18, where abortion is 

noted as an "immutable" risk factor (meaning, once this pregnancy has started, there is 

no intervention to correct for the increased risk. Example of immutable factor: 

Congenital incompetent cervix). Obviously, in the case ofindllcOO abortion, this risk 

factor is totallv avoidable, if the woman is given adequate informed consent prior to 

the abortion and chooses NOT to have the abortion. The truth is, induced abortion 

is a preventable risk factor fol' future preterm birth: Do not have the abortion, and 

you will not have the associated increased risk of preteI'm birth. 

The latest statistics in the USA (2002) show a preterm (less than 37 weeks) birth rate of 

~ Of these, Early Preterm Birth (EPB-under 32 weeks, infants weighing under 

1500 grams, or about three pounds.) is at 7.8%, the highest rate in the past 30 years 

of stats. As noted in the studies above. previous induced abortions' have an 

inordinately increased association with "extreme" (<27 wk) and "early"( <32 wk) 

premature deliveries (compared to 32" 37 week premature births.) Thus, abortion very 

likely will also have an inordinately increased association with cerebral palsy and other 

disabilities linked to extreme prematurity .. 

The total prematurity rate for women in America before 1970, before abortion became 

legal and common, was approximaely 6%.. It is of interest to note that in Ireland, 

where induced abortion is illegal, the prematurity rate in 2003 was 5.48%, less than 

half the U.S. rate of 12.3%. Is there a message here?? . 

Further very interesting statistics come from the Polish experience. Between 1989 and 

1993. Poland's induced abortion rate decreased 98%due to a new restrictive abortion 

law. The Demographic Yearbook of Poland reports that, between 1995 and 1997 the rate 

of extremely preterm births «28 weeks gestation) dropped by 21 %. Is there a message 

here?? 

Induced abortion has a significant association with subsequent premature birth, and 

particularly "very" premature birth (i.e, before 32 weeks gestation). "Very" 

premature birth has a significant 8.'lSociation with cerebral palsy and other 

developmental difficulties. 

AAPLOG calls upon the involved medical disciplines, (in particular, perinatologists 

and neonatologists) to recognize this reality, and to act in the best interest of the 

women and babies who are at risk. Public education and adequate informed 

consent are an essential place to start. But all physicians caring for women mnst be 

cognizant of this preventable risk factor, and educate their vulnerable patients 

accordingly. 

Updated 12-08 
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Eighteen (18) Statistically Significant studies showing an association of Abortion 

with subsequent Very PreTerm Birth, and Abortion with Very Low Birth Weight 

I Reime B, Schuecking BA, Wenzlaff P. Reproductive Outcomes 

in Adolescents Who Had a Previous Birth or an Induced Abortion 

Compared to Adolescents' First Pregnancies. BMC Pregnancy 

and Childbirth 2008;8:4 

2+ Voigt M, Olbertz D, Pusch C, Krafczyk D. Briese V, Schneider KT. 

The influence of previous pregnancy terminations, miscarriages, and 

still-birth on the incidellce of babies with low birth weight and 

premature births as well as somatic classification of newborns. 

Z Oeburtshilfe Neonato! 2008;212:5-12 

3 Smith GCS, Shah I, White IR, Pell JP, Crossley JA, Dobbie R. 

Maternal and biochemical predictors of spontaneous pretei'm birth 

among nulliparous women; a systematic analysis in relation to 

degree of prematurity. International J Epidemiology 2006;35(5): 

1169-1177 

4 Stang P, HammolldAO, Bauman P. Induced Abortion Increases 

the Risk of Very Preterm Delivery; Results from a Large Perinatal 

Database. Fertility Sterility. Sept 2005;S159 [Study only published 

as an abstract] 

5+ Moreau C, Kaminski M, Ancel PY, Bouyer J, et al. Previous 

induced abortions and ·the risk of very preterm delivery: results of 

the EPIPAOE study. British J Obstetrics Gynaecology 2005; 112(4): 

430-437 [abstract online: www. 

blackwell-synergy.comilinks/doilIO. I111/j. 1471-0528.2004.004 78.x!abs! J 

6 Ancel PY, Lelong N, Papiemik E, Saurel-Cubizolles MJ, Kaminski M. 

History of induced abortion as a risk factor for pretei'm birth in European 

countries: results ofEUROPOP survey. Human Reprod 2004;19(3):734-740. 

7+ Ancel PY, Saurel-Cubizolles M-J, Renio OCD, Papiernik E, BTeart G. 

Very and moderate pretei'm births: are the risk factors different? 

British J Obstetrics Gynaecology 1999;106: 1162-1170. 

8+ Zhou W, Sorenson HT, Olsen J. Induced Abortion and Subsequent' 

Pregnancy Duration. Obstetrics & Gynecology 1999;94:948-953. 

9+ Martius JA, Steck T, Oehler MK, WulfK-H. Risk factors associated 

with pretei'm «37+0 weeks) and early pretei'm «32+0 weeks): univariate 

and multi-variate analysis of 106 345 singleton births from 

1994 statewide perinatal survey of Bavaria. European J Obstetrics 
132 


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Gynecology Reproductive Biology 1998;80: 183-189. 

10+ Lumley J. The association between prior spontaneous abortion, 

prior induced abortion and pretenn birth in ftrst singleton births. 

Prenat Neonat Med 1998;3:21-24. 

11 + Lumley J. The epidemiology of preterm birth. Bailliere's Clin 

Obstet Gynecology 1993;7(3):477-498 

12+ Algert C, Roberts C, Adelson P, Frammer M. Low birth weight 

in New South Wales, 1987: a Population-Based Study. Aust New 

Zealand J Obstet Gynaecol 1993;33:243-248 

13+* Zhang J, Savitz DA. Preterm Birth Subtypes among Blacks 

and Whites. Epidemiology 1992;3:428-433. 

14+ Mueller-Heubach E, Guzick DS. Evaluation of risk scoring 

in a preterm birth prevention study of indigent patients. Amer 

J Obstetrics & Gyneco11989;160:829-837. ' 

15+ Lumley J. Very low birth-weight (less than 1500g) and 

previous induced abortion: Victoria 1982-1983. AustNZ J 

Obstet GynecolI986;26:268-272. 

16 Schuler D, Klinger A. Causes oflow birth weight in 

Hungaty. ActaPaediatrica Hungarica 1984;24: 173-185 

17+ Levin A, Schoenbaum S, Monson R, Stubblefield P, 

Ryan K. Association of Abortion With Subsequent Pregnancy 

Loss. JAMA 1980;243(24):2495-2499 

18 Van Der Slikke JW, Treffers PE. Influence of induced abortion 

on gestational duration in subsequent pregnancies. BM] 1978; 

1 :27()"272 [>95% conftdent of preterm risk for gestation l,:!ss 

than 32.0 weeks]. 

* studies that included spontaneous and induced 

abortions (SlA) but did not report PTB/LBW risk separately for ead 

+ studies that found dose/response (the more SIAs, the higher the risk) 
133 


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BIBLIOGAPHY OF 112 STUDIES SHOWING THE 

ABORTION/SUBSEQUENT PRETERM BIRTH ASSOCIATION 

19608 

1 Barsy G, Sarkany J. Impact of induced abortion on the birth rate 

and infant mortality. Demografia 1963;6:427-467. 

2 Miltenyi K. On the effects of induced abortion. Demografia 

1964;7:73-87. 

3 Furusawa Y, Koya Y. The Influence of artificial abortion on delivery. 

In: Koya Y. ed. Harmful effects of induced abortion. Tokyo: 

Family Planning Federation of Japan,1966:74-83. 

4 Arvay A, Gorgey M, Kapu 1. La relation entre les avortements 

(interruptions de Ia grossesse) et les accouchements prematures. 

Rev Fr Gynecol Obstet 1967;62:81-86 

1970s 

5 Drac P, Nekvasilova Z. Premature termination of pregnancy after 

previous interruption of pregnancy. Cesk Gynekol1970;35: 

332-333. 

6 Dolezal A, Andrasova V, Tittlbachova S, et al. Intermption of 

pregnancy and their relation to premature Iabous and hyptrophic 

foetuses. Cesk Gyneko11970:36:331 

7 Pantelakis SN, Papadimitriou GC, Doxiadis SA.Influence of 

induced and spontaneous abortions on the outcome of 

subsequent pregnancies. Amer J Obstet Gynecol. 1973;116: 

799-805. 

! 18 Van Der Slikke JW, Treffers PE. Influence of induced abortion on 

gestational duration in subsequent pregnancies. BMJ 1978;1: 

270-272 [>95% confident of preterm risk for gestation less than 

32.0 weeks]. 

9 Richardson J A, Dixon G. Effect of legal termination on subsequent 

pregnancy. British Med J 1976;1:1303-1304. 

t 10 Papaevangelou G, Vrettos AS, Papadatos D, Alexiou C. The 

Effect of Spontaneous and Induced Abortion on Prematurity 

and Birthweight. The J Obstetrics and Gynaecology of the British 

Commonwealth. May 1973;80:418-422. 
134 


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23 Pziewulska W. Abortion in the past versus the fate of the 

subsequent pregnancy. State of the newborn. Ginekol Pol 

1973;44;1143-1148 [Poland]. 

24 Kaminski M, Goujard J, Rumeau-Roquette. Prediction of 

low birthweight and prematurity by a multiple regression 

analysis with maternal characterisitics known since the beginning 

of the pregnancy. Inti J Epidem 1973;2:195-204 

25 Chabada J, Pontuch A, Sutta I, Pohlova G Interruptions of gravidity 

as a cause of premature labour Cesk Gynekol 1974;49(5):329·330 

26 Fredrick J .. Antenatal identification of women at high risk of 

spontaneous preterm birth. BJOG 1976;83:351-354 

27 Pohanka 0, Balogh B, Rutkovszky M. The impact of abortion 

on the birth weight of newborns. Orb Heti11975;116:1983-1989 

28 Mikolas M. The effect of the legalization of abortion on public 

health and some of its soCial concomitants in Hungary. 

Demografia 1973;16:70-113 

29 Link M, Wichm.ann A. Pregnancy in adolescents. Zentrabl Gynekol 

1976;98(11):682-689 ' 

30 Knarre P. Influence of abortions and interruptions of pregnancy in 

subsequent deliveries. II Cause oflabor. Zentrabl Gynekol 

1976;98(10):591-594 

31 Kreiblich H, Ehring E. Zentralfl Gynokol 1978;100(19): 1254-1260 

32 Macku F, Rokytova V, Titmann O. Artificial Interruption of Pregnancy 

in Primigravidae as a risk factor in future pregnancies. Cesk Gynekol 

1918;43(5):340-343 

33 Zwahr C, Coigt M. Kut:lz L, Thielemann F, Lubinski H. Multidimensional 

investigations to elucidate relationships between case histories of . 

interrupted pregnancies and premature deliveries and low birth weight 

Zentrabl Gynekol 1979;101(23):1502-1509 

19808 . 

34 Zwahr C, Voigt M, Kunz L, et a).. Relationships between 

interruption abortion, and premature birth and low birth weight. 
135 


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46 Schuler D, Klinger A. Causes of low birth weight in Hungary. 

Acta Paediatrica Hungarica 1984;24:173-185 

47 Pickering RM, Forbes J. Risk of pre term delivery and smallfor-gestational age infants following abortion: a population study. 

British J Obstetrics and Gynecology 1985;92: 1lO6-1112. 

! !+48 Lumley J. Very low birth-weight (less than lSOOg) and previous 

induced abortion: Victoria 1982-1983. Aus! NZ J Obstet 

Gynecol 1986;26:268-272. 

+49 Shiono PH, Lebanoff MA. Ethnic Differences and Very 

PreteI'm Delivery. Am J Public Health 1986;76:1317-1321. 

50 Peterlin A Ardolsek L. The effect of induced abortion in 

adolescence on the manifestations of spontaneous abortion, 

premature abortion, and birth weight. Jugos! Ginekol 

Perinatol May-Aug 1986;26(3-4):49-52 

51 Ross MG, Hobel CJ, Bragenier JR, Bear MB, Bemis RL. 

A simplified risk-scoring system for prematurity. Amer J 

Perinatology 1986;3:339-344 

52 Lieberman E, Ryan KJ, Monson RR, Schoenbaum SC. Risk 

Factors Accounting For Racial Differences in the rate of 

premature birth. NEJM 1987;317:743-748. 

53 Seidman DS, Ever-Hadani P, Slater PE, Harlap S, et al. Childbearing after induced abortion: reassessment of risk. J 

Epidemiology Community Health 1988;42:294-298. 

54 Zwahr, C, Neubert D" Triebel U,Voight M, Kruppe1 KH. 

Correlation between some environmental, anamnestic and 

social markers of pregnant patients and the delivery of 

autotrophic premature and hypotrophic newborn infants. 

Zentralbl Gynakol 1988;110:479-487 

I! +55 Mueller-Heubach E, Guzick DS. Evaluation of risk scoring in 

a preterm birth prevention study of indigent patients. Am ] 

Obstetrics & Gyn 1989;160:829-837. 

[990s 

+56 Vassa L-K, Chryssa T-B, Golding J. Previous obstetric history 

and subsequent preterm delivery in Greece. European J 

Obstetrics & Gynecology Reproductive Biology 1990;37: 
136 


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69 Guinn D, Goldenberg RL, Hauth JC, Andrews WA et aI. Risk 

factors for the development of preterm premature rupture of 

membranes after arrest of preterm labor. AJoo 1995; 173 

(4);·1310-1315. 

70 *Hillier SL, Nugent RP, Eschenbach DA, Krohn MA,et al. 

Association Between Bacterial Vaginosis And Preterm 

Delivery Of A Low-Birth-Weight Infant. NEJM 1995;333: 

1737-1742. 

71 Khalil AK, EI-Amrawy SM, Ibrahim AG, et al. Pattern of growth 

and development of premature children at the age of two and 

three years in Alexandria, Egypt. Eastern Mediterranean 

Health Journal 1995; 1(2): 186-193. 

72 Meis PJ, Michielutte R, Peters n, Wells HE. Factors associated 

with preterm birth in Cardiff, Wales. Amer J Obstet Gyneco11995; 

173:590-596 

+73 Lang 1M, Lieberman E, Cohen A. A Comparison of Risk 

Factors for Preterm Labor and Term Small-fQr-Gestational-Age 

Birth. Epidemiology 1996;7:369-376. 

*74 Hagan R, Benninger H, Chiffings D. Evans S, French H. Very 

preterm birth - a regional study. Part 1: Maternal and obstetric 

factors. BJOG 1996; 103:230-238 

75 Chie-Pein Chen, Kuo-Gon Wang, Yuh-Cheng Yang, Lai-Chu See. 

Risk factors for preterm birth in an upper middle class Chinese 

population. Eur J Obstet Gynecol Reprod Bio 1996;70(1):53-59 

76 Jacobsen G, Schei B, Bakketeig LS. Prepregnant 

reproductive risk and subsequent birth outcome among 

Scandinavian parous women. Norsk Epidemiol 

1997;7(1):33-39 

!!+77 Lumley J. The association between prior spontaneous 

abortion, prior induced abortion and preterm birth in first 

singleton births. Prenat Neonat Med 1998;3:21-24. 

!!+ 78 Martius JA, Steck T, Oehler MK, Wulf K-H. Risk factors 

associated with preterm «37+0 weeks) and early preterm 

«32+0 weeks): univariate and multi-variate analysis of 

106345 singleton births from 1994 statewide perinatal 

survey of Bavaria. European J Obstetrics 

& Gynecology Reproductive Biology 1998;80:183-189. 
137 


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and Prematurity in Botswana. J Biosoc Sci 2001;33(3):391-403 

89 Henriet L, Kaminski M. Impact of induced aQortions on subsequent 

pregnancy outcome: the 1995 French national perinatal slil"Vcry. 

BJOG 2001;108(10): 1036-1042 

90 Grimmer I, Buhrer C, Dudenhausen JW. Preconceptional 

factors associated with very low birth weight delivery: a 

case control study. BMC Public Health 2002; 2:10 [Germany]. 

91 Balaka B, Boeta S, Aghere AD, Boko K, Kessie K, Assimadi K. 

Risk factors associated with prematurity at the University of 

Lme, Togo. Bull Soc Pathol Exot Nov 2002;95(4):280-283 

92 Han WH, Chen LM, Li CY. Incidences of and Predictors for Preterm 

Births and Low Birth Weight Infants in Taiwan. Chinese Electronic 

Periodical Services 2003:131-141 

93 EI-Bastawissi AY, Sorensen TK, Akafomo CK, Frederick 10, Xiao R, 

Williams MA. History of Fetal Loss and Other Adverse Pregnancy 

Outcomes in Relation to Subsequent Risk of Preterm· Delivery. 

Maternal Child Health J 2003;7(1):53-58 

94 Reime B, Schuecking BA, WenzlaffP. Perinatal outcomes of 

teenage pregnancies according to gravidity and obstetric history. 

Annals of Epidemiology 2004;14(8):619-619 [German subjects] 

http://www.sciencedirect.comlscience?_ob;::3DGatewayURL&_method;::3DcitationSearc 

h&_uoikey::::3DB6T44-4D8V8F5-

2R&_origin::::3DSDEMFRASCII&_ version=3D 1 &md5=3De7360 lc4adf512cbb49d79b5 

56183ab7 

!!+95 Ancel PY. Lelong N. Papiernik E. Saurel-Cubizolles MI, 

Kaminski M. History of induced abortion as a risk factor 

for preterm birth in European countries: results of 

EUROPOPsurvey. Human Repro 2004; 19(3): 734-740. 

96 Umeora OUJ, AndeABA, Onuh SO, Okubor PO, Mbazor JO. 

Incidence and risk factors for preterm deli very in a tertiary health 

institution in Nigeria. J Obstetrics Gynaecology Nov. 2004; 

24(8):895-896 

H+97 Moreau C, Kaminski M. Ancel PY, Bouyer J, et al. Previous 

induced abortions and the risk of very preterm delivery: 

results of the EPIPAGE study. British J Obstetrics 

Gynaecology 2005;112(4):430-437 [France] 
138 


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colony-stimulating factor and spontaneous pre term delivery. Acta 

Obstectica et Gynecologica 2007:86: 1103-1110 

108 * Brown TS, Adera T, Masho Sw. Previous abortion and the risk of 

low birth weight and preterm births. J Epidemiol Commun Health 

2008;62: 16-22 

109 Reime B, Schuecking BA, WenzlaffP. Reproductive Outcomes in 

Adolescents Who Had a Previous Birth or an Induced Abortion Compared 

to Adolescents' First Pregnancies. BMC Pregnancy and Childbirth 

2008;8:4 

! !+110 Voigt M, Olbertz D, Fusch C, Krafczyk D. Briese V. Schneider KT. 

The infuluencc of previous pregnancy terminations, miscarriages, and 

still-birth on the incidence of babies with low birth weight and 

premature births as well as somatic classication of newborns. 

Z Geburtshilfe Neonatol 2008;212:5-12 

111 Freak-Poli R, ChanA, Gaeme J, Street J. Previous abortion and risk 

of preterm birth: a population study. J Maternal-Fetal Med Jan. 2009; 

22(1):1-7 

112 Vpoit M, Henrich W, Zygmunt M, Friese K, Stral,lbe S, Briese V. 

Is induced abortion a risk factorin subsequent pregnancy? Journal 

Perinatal Medicine 2009;37: 144-149 

The following is a significant APB study but is not part of the 'official' list 

above since it involves predominently 'illegal' induced abortions: 

Okonofus FE, Onwudiegwll D, Odutayo R. Pregnancy outcomes after 

illegal induced abortions in Nigeria: a retrospective referenced historical 

study. Africa J Med Science 1994;23: 165-169 

* studies that included spontaneous and induced abortions (3IA) 

but did not report PTB/LBW risk separately for each 

+ studies that found dose/response (the more SIAs, the higher the risk) 

!! Significant AbortionNPB ('{ery Preterm Birth) andlor AbortionlVLBW (Very Low 

Birth Weight) 
139 


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The American Association of ProUte Obstetricians and Gynecologists 

Is induced 

RECENT STUDY ON ABORTION 

PRETERM BIRTH 

2008 

a risk factor subsequent pregnancy? 

o Feb;212( ): 

lDepartment of Obstetrics and Gynecology, Ernst-Moritz-Arndt-University of 

Greifswald, Germany. 

Abstract To determine whether a history of terminations 

of pregnancy influences subsequent pregnancies in terms of pregnancy 

prematurity and neonatal biornetrics. Patients and methods: 

Based on the perinatal statistics of German federal states, data 

of 247,593 primiparous women with singleton pregnancies born 

between 1998 and 2000 were analyzed. The control group consisted of 

primiparous women without previous induced abortions. Maternal age 

was adjusted for. Results: There was an trend towards an 

increased rate of delivery at weeks' gestation and 

early preterm delivery at weeks' gestation in women who had 

pregnancy terminations. For the cohort of 28-30 years, the 

observed rates of prematurity in women with one and with 

previous lnduced abortions were 7.8% and respectively, 

to 6.5% ill the control {P==O.OlS). Preceding 

terminations of pregnancy did not alter the rate of small-forgestational-age newborns. Psychosocial stress and symptoms 

associated with prematurity such as cervical incompetence and vaginal 

bleeding before and after 28 weeks of gestation occurred more 

frequently in women with previous induced abortion compared to the 

control group (P<O.OOOl). Conclusion: The rate of preterm births 

increases with the number of preceding abortions. Similarly, symptoms 

associated with prematurity are more common. The rate of small-fornewborns was not affected by preceding termi nations 

of pregnancy. 
140 


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AAPLOG - AMERICAN ASSN OF PRO-LIFE OB/GYNS 

www.aaplog.orgprolifeob@aol.com 

Sept 08 

AND BIRTH 

THE 10M REPORT: A CRACK IN THE STONE WALL 

The ACOG has a declared position on long term complications of 

induced abortions. Simply stated, they declare: THERE ARE NO 

SIGNIFICANT LONG TERM COMPLICATIONS. Lest you feel we are 

unfair to the ACOG, we quote from the ACOG Practice Bulletin 

unchanged since 2001, and re-validated as an ACOG position in 

their Compendium of Selected Publications: "Long term 

sometimes attributed to surgical abortion include potential 

function, cancer incidence, and psychologic 

However, trle medical literature, when carefully evaluated, 

no significant negative impact on any factors 

with surgical abortion." This Bulletin was replaced ill Oct, 2006 with 

Practice Bulletin which not repeat this misinformation. 

neither is there correction of this misinformation in any 

ACOG literature we have seen to date. Additionally, the ACOG 

Amicus Brief in the January 2006 Supreme Court case on 

notification (Ayotte vs Plallned Parenthoocj of Northern New 

England), states unequivocally, "The evidence belies any serious long 

term health consequences of abortion for minors. Contrary to the claims of 

the State and its amici, there is simply no reliable evidence that abortions 

are harmful to minors' health. Extensive reviews have concluded that 

there are no clocumented negative psychological or medica! sequelae to 

abortion among teen-aged women. Minors who obtain an abortion are not 

at risk of complications in future pregnancies, future medical 

problems, or future psychological problems." That Brief should be current 

enough to define ACOG's declared position Oil long-term abortion 

complications). 

However, in July, National of Sdence's Institute of 

Medicine produced a book entitled" Preterm Birth: 

and Prevention." This is a volume with the very latest and most 

information. A July 06 ACOG news release highly praises this 

new work, and notes that "ACOG is pleased to be a cosponsor of this 

report because the impact of preterm birth is a major public health problem 

both in the US and worldwide," If one scrutinizes the report very carefully. 
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one will find. in the Appendix, one will find a single entry (on page 517-18) 

in which induced aboriion is noted as an "immutable" risk factor (meaning, 

"once you are if you have a history of previous induced abortion, 

this is an unalterable risk factor." 

There are a few tllings on the "immutable" list that can be changed by 

action prior to pregnancy--the first is multiple gestations, which sometimes 

can be changed, wilen related to assisted reproductive techniques. A 

couple which MIGHT be able to be changed, are Imv prepregnancy weight and urogenital infections. 

The elepilant in the "risk factor room" is induced abortion, which can be 

changed by simply not obtaining the induced abortion in the first place--this 

would be primary prevention. There may not be any current secondary 

prevention, but there r-ertainly can be primary prevention. 

The "immutable" risk factor of induced abortion could be abolished as a 

risk factor in virtually all circumstances with adequate informed consent 

and some forward thinking ... 

But what about the ACOG position of denial of a risk association? What 

about the Amicus Brief issued for the 2006 Supreme Court case? They 

state categorically, concerning induced abortion. that the medical 

literature "clearly demonstrates no significant negative impact on" 

"reproductive function." They assure the Supreme Court Justices that 

induced abortion in "minors" renders them "not at greater risk of 

complications in future pregnancies," So what are we to believe?----the 

ACOG Amicus brief, or Hie ACOG sponsored and publicly praised 10M 

report? These positions soem to contradict each other. Perhaps a crack 

has developed in the stone wall of denial. 

ACOG is a partner in the national March of Dimes campaign to reduce the 

number of premature births. To date, the word "abortion" has not 

appearod on Ule MOD website information concerning preventable risk 

factors for preteI'm birtils. Surely ACOG will advise MOD that the recent 

Institute of Medicine textbook validates the abortion as a risk factor, so 

MOD can, in turn, adequately inform the women they seek to serve 

regarding this cornpletely preventable "immutable" protem) birth risk factor. 
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Disparities in Preterm Birth: 

The Patterns Tell Us We Need to Address Social Factors. 

Paula Braveman, MD, MPH 

Professor of Family and Community Medicine and 

Director, Center on Social Disparities in Health 

University of California, San Francisco 

Braveman@fcm.ucsf.edu 

415-476-6839 

Submitted to the Subcommittee on Health of the House Committee on Energy and 

Commerce, relevant to a hearing on Preterm Birth May 12, 2010 

Key points 

• The large and persistent black-white disparity in preterm birth (PTB) is not 

explained by the recognized causes of PTB; for example, black women are less 

likely than white women to smoke, and the disparity persists after considering diet 

and drug use. 

• African and Afro-Caribbean immigrants to the U.S. have PTB rates similar to 

those of U.S. whites. This pattern strongly suggests that the causes of the blackwhite disparity are social, rather than genetic. . 

o Other features of the social patterns ofPTB also point to social causes. 

Although PTB rates decline with increasing income or education among 

black women as well as white women, the relative black-white difference 

in PTB rates (the ratio of the rates) is much larger among more 

educated/affluent women than among poor/less educated women. This 

also suggests social rather than genetic causes. 

• The observed patterns ofPTB are consistent with a potential role for stressful 

circumstances experienced by women during childhood; stress could be related to 

financial hardship or awareness of racial discrimination. 

o Financial hardship and insecurity are stressful, and regardless of their 

current income or education, black women are more likely than white 

women in similar current socioeconomic circumstances to have 

experienced worse economic circumstances while growing up. This could 

help explain why the racial disparity in PTB is greater among more 

educated/affluent women than among poorer/less educated women. 

o The patterns also could be explained by chronic stress associated with 

awareness of racial discrimination - for example, a woman may be aware 

that she belongs to a socially less-valued group, and may be considered 

inferior based on her racial group, even if she does not personally 

experience overt incidents of racial discrimination. This awareness could 
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Racial Disparities in Preterm Birth: 

The Patterns TeO Us We Need to Address Social Factors 

Trends in the black-white disparity in preterm birth 

For decades, large disparities in birth outcomes have been observed between babies born 

to African-American (black) women and those born to European-American (white) 

women. Adverse birth outcomes - that is, being born '~too early" (premature or preterm 

birth, before 37 completed weeks of pregnancy) or "too small" (low birth weight, less 

than 5 Y:z pounds)-are powerful predictors not only of infant survival, but of child 

health, development, and serious disability, and, according to recent research, also of 

chronic disease in adulthood. The disparities have been persistent, until recently when 

relative disparities began to narrow somewhat, for undesirable reasons: the rates of both 

preterm birth (PTB) and low birth weight (LBW) worsened among white women, with 

little (PTB) or no (LBW) improvement among black women. (For simplicity, throughout 

this paper "black" and "white" are used to refer only to non-Hispanic women.) 

The known causes of adverse birth outcomes do not explain the disparities. Known 

causes of both PTB and LBW include use of tobacco, excessive alcohol (particularly in 

the first trimester), use of illegal drugs, low pre-pregnancy weight, inadequate weight 

gain during pregnancy, very short maternal stature, and chronic disease. Studies taking 

these factors into account, however, have still observed sizable black-white disparities, 

and the disparities persist even after taking income or education into account. 

A number of other causes have been suspected, but to date no definitive evidence has 

established any of them. Many researchers have hypothesized that infectionsprincipally genital infections such as Bacterial Vaginosis or oral/gingival infectionswere the cause, because these infections are more common among black women .. This 

seems unlikely, however, because experiments in which the infections were successfully 

treated have not consistently improved birth outcomes, suggesting that there are 

unmeasured factors associated with the infections that are the actual causal agents. Some 

scientists have thought that exposure to certain environmental toxins might be the 

answer, and others have implicated work that is physically demanding -e.g., requiring 

one to be on one's feet for extended periods of time during pregnancy-but neither 

theory has consistent evidence to support it. 

A widely held theory is that the differences are genetic in nature, but no one has 

identified a "PTB" or "LBW' gene or set of genes. The processes involved in PTB are 

likely to be complex, involving cascades of factors that mlj.y interact with multiple other 

factors; it is reasonable to question whether such complex cascades of factors would be 

likely to sort out through the process of natural selection along racial/ethnic lines. 

Furthermore, as will be discussed later in this paper, black immigrants to the U.S. from 

Africa and Afro-Caribbean nations have birth outcomes that are relatively similar to those 

of white women in the D.S., while the birth outcomes ofD.S.-bom daughters of those 

immigrants look like those of other African-American women. These patterns suggest an 

3 
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Among both black and white women, PTB and LBW rates decline (improve) with 

increasing income or education. However, the relative difference (the ratio of the rates) 

between black and white birth outcomes actually increases (worsens) with higher income 

or education. For example, in recent statewide data from California (where one in 7 US 

births occur), among poor women, blacks had 1.3 times the rate of LBW as whites; 

among women with incomes over two times the poverty level, however, black women 

were more than twice (2.5) times as likely as white women to have a LBW birth. The 

same pattern has been seen in national data, and patterns are similar for PTE. As with 

the birth outcomes ofimmigrants and their U.S.-born daughters, it also is difficult to 

explain this pattern as genetically based. 

How could this perhaps counter-intuitive pattern be explained? Why would higher 

income/education black women do worse relative to their similar-income/education white 

counterparts? Two explanations seem reasonable, both having to do with stress: stress 

related to unmeasured financial hardship or insecurity, and stress related to awareness of 

racial discrimination. 

Financial hardship is stressful, and experiences of chronic stress, particularly during 

childhood, may have the most potential for damaging physiologic systems with potential 

implications for PTB. Health studies rarely measure socioeconomic experiences in 

childhood, and black women of a given current income or education are far more likely 

than their same-current-income/education white counterparts to have experienced worse 

socioeconomic conditions as children. There may be less difference between currently 

poor black and white women in how poor they were in childhood and the characteristics 

of the neighborhoods they lived in as children, than between currently non-poor black 

and white women. Worse socioeconomic conditions could be stressful in themselves, 

and contribute to fainily disruption, which adds to the stress. More affluent black women 

may face more stress than similarly affluent white women due to greater needs to 

financially support family, fnends, or partners, than their white counterparts. And 

college-educated black women face the added stress of haVing fewer similarly-educated 

black men with whom they might partner, given the high rates of incarceration and low 

rates of college graduation among black men in the U.S. 

In addition to the stress of financial hardship and associated social stressors, chronically 

experiencing or anticipating discriminatory treatment could be stressfuL Being aware of 

racial discrimination, and being vigilant to be prepared to respond to it if it occurs, also 

could be quite stressfuL In focus groups with African-American women in California, 

my colleagues and I were stuck by the extent to which black women -both low-income 

and not low-income--carried around with them a constant, gnawing awareness and 

anxiety about when the next incident, overt or subtle, might occur to them or their 

children. More educated and affluent African-American women may ironically be more 

exposed to experiences of racial discrimination, because they are more likely to be 

working, shopping, and potentially residing with whites, than their less educated/affluent 

black counterparts. This theory must be tested empirically, but it is biologically plausible 

given what we know about the physiology of stress, which is discussed below. 

5 
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response, with the potential for resulting in significant damage over time to organs and 

systems, as mentioned in the discussion of stress (above). 

What are the solutions? 

No one has definitive knowledge of the causes of racial disparities in birth outcomes, but 

we do know enough to know that there are no simple solutions. The patterns are social, 

and the solutions therefore must be social, whether or not there is any additional 

contribution that new biomedical therapies can make. The patterns strongly suggest a 

role for chronic social disadvantage, both related to economic hardship and its social 

consequences, and related to living in a society where racial discrimination still exists, 

perpetuated by societal structures such as racial residential segregation, even when there 

is no longer conscious intent to discriminate. The solutions to racial disparities in PTB 

are ones likely to address most racial disparities in health - initiatives that will bring 

economic and social opportunities to communities that are marginalized. 

Because conditions in neighborhoods can be such an important -and modifiable--

determinant of a person's ability to escape poverty and its adverse health effects, efforts 

like the current federal administration's "Promise Neighborhoods" initiative -combining 

early childhood development programs, improving schools, supporting families, and 

engaging communities-- will be crucial for breaking the intergenerational cycle of 

poverty and despair that is one of the most important underlying factors of racial 

disparities in health in this country. Public dialogue about race and racism will also be 

important, but cannot take the place of concrete measures to change the material and 

social conditions of African-Americans. Achieving more equality in social and economic 

opportunities will ultimately contribute more to racial equality -in health overall, and in 

PTE in particular-- than discussions of racism. 

I am collaborating with the California Department of Pub lie Health Maternal, 

Adolescent, and Health Division (MCAH) to develop and implement a science-based 

approach to reducing the racial disparity in PTB in California, which focuses on 

empowerment, capacity-building and social support among African-American women. 

This approach should be considered for Healthy Start and throughout Medicaid. 

Referenees 

Institute of Medicine, Preterm Birth: Causes, Consequences, and Prevention. 

Washington, D.C.: The National Academies Press, 2007. 

Institute of Medicine. From Neurons to Neighborhoods: The science of early child 

development. Washington, D.C.: National Academies Press, 2000. 

Mc Ewen BS, Gianaros PJ. Central role ofthe brain in stress and adaptation: links to 

socioeconomic status, health, and disease. Ann N Y Acad Sci. 2010 Feb;1186:190-222. 

Collins, JW, Jr, David RJ. Racial disparity in low birth weight and infant mortality. 

7 

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"Prematurity and Infant Mortality: What Happens When Babies Are Born Too E

Prepared Supplementary Handout for Hearing 

Nicholas Eberstadt, Ph.D. 

Henry Wendt Chair in Political Economy 

American Enterprise Institute 

eberstadt@aei.org 

Committee on Energy and Commerce 

Subcommittee on Health 

U.S. House of Representatives 

Washington, D.C. 

May 13,2010 

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Figure 1: U.S. Infant Mortality Rates by Birthweight, 1985-2005 

'." __ ,0/_ ••• '. ___ M'_"'_'m' ••. .•••• 

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1985 1990 1995 

-+- Less tllan 500 grams __ 500-999 grams 

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2000 

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2005 

Source: CDC/NCHS, National Vital Statistics System, Linked Birth/Infant Death Data Set. From Health, United States

Table 18. Available at http://www.cdc.gov/nchs/data/hus/hus09.pdf. 

Insert graphic folio 156 76576A.100tjames on DSK6SPTVN1PROD with HEARING

Figure 2A: Infant mortality rate for early/premature births by gestation (22-

23 weeks): USA vs. Selected European Countries, 2004 

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Source: NCHS linked birth/infant death data set (for U.S. data), and European Perinatal Health Report (for European 

From Marian F. MacDorman, Ph.D., and T.J. Mathews, M.S., "Behind International Rankings of Infant Mortality: How 

United States Compares with Europe," NCHS Data Brief, Number 23, November 2009. Table 2, available at 

http://www.cdc.gov/nchs/data/databriefs/db23.htm. 

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Figure 28: Infant mortality rate for early/premature births by gestation (24-

27 weeks): USA vs. Selected European Countries, 2004 

Poland Scotland Austria Finland Denmark England Northern United NOlWay 

and Wales Ireland States 

Source: NCHS linked birth/infant death data set (for U.S. data), and European Perinatal Health Report (for Europ

From Marian F. MacDorman, Ph.D., and T.J. Mathews, M.S., "Behind International Rankings of Infant Mortality: H

United States Compares with Europe," NCHS Data Brief, Number 23, November 2009. Table 2, available at 

http://www.cdc.gov/nchs/data/databriefs/db23.htm. 

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Figure 2C: Infant mortality rate for early/premature births by gestation (28· 

31 weeks): USA vs. Selected European Countries, 2004 

Poland Scotland Finland NOlway NOlthem England United Austria Denmark 

Ireland and Wales States 

Source: NCHS linked birth/infant death data set (for U.S. data), and European Perinatal Health Report (for Europea

From Marian F. MacDorman, Ph.D., and TJ. Mathews, M.S., "Behind International Rankings of Infant Mortality: Ho

United States Compares with Europe," NCHS Data Brief, Number 23, November 2009. Table 2, available at 

http://www.cdc.gov/nchs/data/databriefs/db23.htm. 

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Figure 20: Infant mortality rate for early/premature births by gestation (32-

36 weeks): USA vs. Selected European Countries, 2004 

Poland NOlthern Sweden England Denmark Finland Scotland United Norway 

Ireland and Wales States 

Source: NCHS linked birth/infant death data set (for U.S. data), and European Perinatal Health Report (for Europea

From Marian F. MacDorman, Ph.D., and T.J. Mathews, M.S., "Behind International Rankings of Infant Mortality: Ho

United States Compares with Europe," NCHS Data Brief, Number 23, November 2009. Table 2, available at 

http://www.cdc.gov/nchs/data/databriefs/db23.htm. 

Insert graphic folio 160 76576A.104tjames on DSK6SPTVN1PROD with HEARING

Table 1: Infant Mortality by Race, Education and Marital Status--USA, 1982 (E

Pilot States, US Linked Birth and Infant Death Files, per 1,000 live births

Years of Education All Races White Black All women 10.5 9.0 21.9 

o to 8 13.0 12.0 27.5 

9 to 11 16.7 12.9 29.1 

12 10.1 8.8 20.0 13 to 15 9.5 8.1 18.6 16+ 8.6 7.9 20.6 

Married women 9.1 8.4 18.2 

o to 8 11.1 10.6 24.5 

9 to 11 12.4 11.1 24.9 

12 8.9 8.4 16.4 13 to 15 8.5 7.8 16.8 16+ 8.3 7.9 19.2 

Unmarried women 20.7 16.2 25.2 

o to 8 20.7 18.1 29.8 

9 to 11 24.9 19.2 30.7 

12 18.6 14.6 23.1 13 to 15 19.9 15.1 20.9 

16+ 18.4 11.6 26.8 

Note: The eight pilot states are Illinois, Indiana, Massachussetts, Michigan, Missouri, New Hampshire, Vermont, and Wisconsin. "All race

races other than black and white. 

Source: National Center for Health Statistics, Pilot Linked Birth and Infant Death File, unpublished data. From Nicholas Eberstadt, "The 

Numbers: Mismeasurement and Misrule," AEI Press, 1995. Table 2.9. 

Insert graphic folio 161 76576A.105tjames on DSK6SPTVN1PROD with HEARING

Table 2: The "Hispanic Paradox": Infant Mortality, Low Birthweight, And Ot

Socio-demographic Characteristics for the US by Ethnicity, c. 2006 

Non·Hispanic American 

Non-Hispanic African- Indian/Alaskan Asian-Pacific 

White American Native Islander His an ie/Latino All US

Low birthweight (% of 

live births) 7.3 14.0 7.5 8.1 7.0 

Infant mortality rate (per 

1.000 live births, 2003-5 

data) I 5.7 13.6 8,4 4.8 5.6 

Child poverty rate 

(children under 18, 

percent) 9.5 33.0 N/A 12.0 26.6 

% of women 18+ 

without HS degree 9.8 19.1 N/A 14.7 38.8 

% of births with no 

prenatal care in first 

trimester 24.0 41.8 44.0 28.9 42.4 

Sources: Low birthweight data from CDC/NCHS, National Vital Statistics System, Birth File. From Health, United States, 2009. Table 11. Available at 

http://www.cdc.gov/nchs/data/hus/hus09.pdf.; 

Infant mortality data from CDC/NCHS, National Vital Statistics System, Linked Birthllnfant Death Data Set. From Health, United States, 2009, Table 20. Available at 

http://www.cdc.gov/nchs/data/hus/hus09.pdf.; 

8.3 

6.8 

16.9 

14.7 

31.7 

Child poverty data from U.S. Census Bureau, Current Population Survey, Annual Social and Economic Supplements; DeNavas-Walt C, Proctor BD, Smith JC. Income, Pov

Health Insurance Coverage in the United States: 2007. Current Population Reports, Series P-60, No 235. Washington, DC: U.S. Government Printing Office, 2008. From H

States, 2009. Table 3. Available at http://WW'N.cdc.gov/nchs/data/hus/hus09.pdf.; 

Prenatal care data from CDCfNCHS, National Vital Statistics System, Birth File. Martin JA, Hamilton BE, Sutton PO, Ventura SJ, Menacker F, Kirmeyer S, Mathews T J. Bir

for 2006. National vital statistics reports. Vol. 57 no 7. Hyattsville, MD; NCHS. 2009. 

Educational attainment data from U.S. Census Bureau, Current Population Survey, 2006 Annual Social and Economic Supplement, Table 1 a, available at 

http://www.census.gov/population/www/socdemo/education/cps2006.htm!. 
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HHS Response to Questions for the Record from 

The Honorable Zack Space 

Subcommittee on Health 

Committee on Energy and Commerce 

U.S. House of Representatives 

May 12,2010 Hearing on 

Prematurity and Infant Mortality: What Happens When Babies Are Born Too Early? 

1, What more can we do to foster the use of telemedicine for the prevention and treatment 

of prematurity? 

Both the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention 

(CDC) support activities that will foster the improvement of care through the use of 

telemedicine. 

NIH defines "telemedicine" as the "use of electronic communication and information 

technologies to provide or support clinical care at a distance. Included in this definition are 

patient counseling, case management, and supervision/preceptorship of rural medical residents 

and health professions students when such supervisinglprecepting involves direct patient care." 

The National Library of Medicine at the NIH has supported a National Telemedicine Initiative 

for many years that includes projects such as the Virtual Hospital and the National Laboratory 

for the Study of Rural Telemedicine (see http://www.nlm.nih.gov/research/telemedinit.html).In 

addition, NIH's Center for Information Technology is making constant efforts to improve the 

technologies critical for telemedicine to be successful in its Biomedical Imaging and 

Visualization Section (see http://cit.nih.gov/Science/CollaborativeResearchlTelemedicine). 

Although no clinical trials on the use oftelemedicine to prevent or address prematurity are 

currently underway, other NIH-supported trials include using telemedicine for smoking 

cessation, and diabetes heart disease treatments, among others. The NIH would welcome grant 

applications proposing the use oftelemedicine for other conditions, including preterm birth. 

CDC agrees that telemedicine, and any technologies that foster communication between and 

among clinicians and hospitals, have the potential to increase the efficiency and accuracy of 

clinical assessment and treatments. This is particularly pertinent to the treatment of newborn 

preterm infants. The CDC, as a public health agency, does not interact with the provision of care 

at the individual level on issues of maternal and infant health. However, the CDC will continue 

to encourage well-organized, state-based perinatal regionalization as a strategy to care for high 

risk women and infants. 

2. What more can we do to support evidence-based initiatives like the Ohio Better Birth 

Outcome Program? 

NIH and CDC agree that a strong evidence base is essential to good patient care and support 

research within their missions to strengthen scientific knowledge on preterm birth. Some 

research examines which health care practices may be beneficial (and which may not be) in 

preventing preterm labor or caring for the mother and infant following a premature birth. 

Programs such as the Ohio Better Birth Outcome program can use new evidence rcsulting from 

this research to improve pregnancy outcomes in their own communities. Ohio also is fortunate 

to have the Ohio Perinatal Quality Collaborative (QPQC). Under the direction of a multidisciplinary steering committee, the QPQC works from the obstetric perspective to decrease 
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HHS Response to Qnestions for the Record from 

The Honorable Zack Space 

Subcommittee on Health 

Committee on Energy and Commerce 

u.S. House of Representatives 

May 12, 2010 Hearing on 

Prematurity and Infant Mortality: What Happens When Babies Are Born Too Early? 

unnecessary intervention, particularly in the late preterm and early term gestations, and from the 

neonatal perspective to improve the quality of newborn care. The work of the QPQC has been 

presented at national meetings and published in peer-reviewed journals. We applaud the efforts 

of the QPQC, and the other states that have similar collaboratives. 

2 
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June 15.2010 

The Honorable Zack Space 

207 Cannon House Omce Building 

Washington. DC 20515 

Dear Representative Space: 

Thank you for the 0PPoltunity to respond to your question regarding expanding 

Congressional support t(lr evidence based initiatives like the Ohio Better Birth Outcome 

program. During my recent visit to the Nationwide Children's Hospital in October 2009 

I was pleased to leam about the Ohio Better Births Outcome and the close atTiliation 

between Nationwide and Ohio State University in several collaborative eflorts to enhance 

outcomes of pregnancy. 

Thus. building on the success of the Ohio program. there are many ways Congress can 

address and combat the serious and costly problem of prematurity. Specific initiatives 

include the following: (I) accelerate the implementation of various provisions included in 

the Patient Protection and Affordable Care Act (P.L. 111-148); (2) increase funding for 

prematurity research; (3) reauthorize the PREEMIE Act (P.L. 109-450) and (4) fund 

maternity care demonstration projects utilizing the nm\' mandatory Prevention and Public 

Health Fund. Pkase find the Foundation's comments below further articulating our 

thoughts about the aforementioned items. 

Aceelerate Implementation of the Following Provisions Included in the Patient 

Protection and Affordable Care Act (P.L. 111-148) 

Quality: The development. dissemination and use of maternity and pediatric 

quality measures represent an important tool for improving maternity and 

pediatric health care and reducing preterm birth and infimt mortality. The 

Children's Health Insurance Program Reauthorization Act (CHIPRA) took an 

important step forward in this arena by calling tor the development of a core set 

of pediatric quality measures. Health reform lurthers this effort significantly. 

calling for a National Strategy for Quality Improvement, development of a core 

set of adult quality measures for usc in Medicaid. and creation of the Center for 

lV1edicare and iv1cdicaid Innovation. As these provisions are implemented, it is 

critical that the unique needs of pregnant women. infants and children are 

recognized. These provisions are a critical opportunity to further development 

and use of maternity and pediatric quality measures. 

Further definition of maternity and pediatric benefits: The inclusion of 

maternity care and pediatric services in the essential benefits package wm be 

instrumental in helping to ensure that pregnant women, intants and children have 

access to the health care they need. As these benefits are further defined. they 

should cover particular services that can help prevent preteI'm birth (such as early 

ultrasounds for accurate gestational dating) as well as those specialty services 

needed by infants and children who are born pretenn. 

Further definition of women's preventive health benefit The requirement that 

all insurance plans cover preventive health services needed by women has the 
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potential to increase access to services that can lower the risk of preterm birth. As 

this benefit is further defined. it should include access to family planning and 

preconception care services. Family planning helps women appropriately space 

pregnancies. which has been found to reduce the risk of prcterm bilth. 

Preconception care allo'ws providers to identify conditions or behaviors that can 

impad a future pregnancy and provide appropriate intervention. 

Smoking Cessation: The Foundation encourages state and federal policymakers 

to implement comprehensive ,Medicaid coverage of smoking cessation provisions. 

A comprehensive tobacco cessation benefit is crucially important for pregnant 

\vomen given the well documented negative impact of smoking on pregnancy 

health and birth outcomes. Pregnant women on Medicaid arc 2.5 times more 

likely than other pregnant women to smoke. Moreover. joint estimates by the 

CDC and CMS. have found that smoking-attributable neonatal health care costs 

for Medicaid total almost $228 million. Clinical trials have shown that. for every 

$1 invested in smoking cessation programs for pregnant women, $7.75 are saved 

in short-term medical costs and an additional $7.63 (in year 2002 dollars) are 

saved in long-term costs by preventing disability among low birth weight infants 

\vho survive. 

Increase Funding for Prematurity Research 

National Children's Study (NCS): Currently in the pilot phase, the NCS is 

tracking the more than 150 children born to stlldy participants. The data Irom this 

important effort will inform the work of scientists in universities and research 

organizations across the nation and around the world. helping them identify 

precursors to disease and to develop new strategies foJ' prevention and 

treatment. The first data generated by the NCS will provide inl\)fmation 

concerning disorders of birth and infancy including preterm birth and its hcalth 

consequences. 

• National Institute of Child Health and Human Development: Increased 

funding will enable NICHD to maintain the momcntum and investments made 

with support provided through the Recovery Act. It will also enable the Institute 

to expand its support lor pretenn birth-related research and to initiate 

establishment of a net\vork of integrated transdisciplinary research centers as 

recommendcd by the Institute of Medicine and the cxperts who participated in the 

Surgeon General's Conference. The causes of pretern1 birth arc multi-factorial 

and necessitate a collaborative approach integrating many disciplines. These nc\\-

centers would serve as a national resource for investigators to design and to share 

ne\v research approaches and strategies to comprehensively address the problems 

of pre term birth. 

Centers for Disease Control and Prevention National Center for Chronic 

Disease Prevention and Health Promotion, Division of Reproductive Health: 

This division works to promote optimal reproductive and intimt health. In 2009. 

CDC created a robust research agenda to prevent preterm birth by improving 

national and state data to track preterm births; developing, implementing and 

evaluating methods for prevention; understanding the problem of late preterm 

birth; and conducting etiologic and epidemiologic studies of early preterm birth. 

Increased funding is needed for the division to continue their important work. 
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Reauthorization of the PREEMIE Act (P.L. 109-450) 

Authorize Trans-Disciplinary Centers for Pretcrm Birth Research: Through 

this approach the Director shall make awards of grants and contracts to public 

andlor nonprofit private entities to pay all or part of the cost of planning. 

establishing, improving and providing basic operating support for transdisciplinary research centers for prematurity. Existing programs related to 

prematurity research include neonatal and maternal-fetal medicine multicenter 

research networks with a focus on clinical trials. This new program would focus 

primarily on basic and translational research and would progress logically over 

time to include the need for interventional and clinical research. To accomplish 

this goal, these centers would benefit from close association or affiliation with 

other NIH-funded centers focused on clinical trials. Research should integrate 

clinical. public health. basic, and behavioral and social science disciplines 

together with bioinformatics. engineering, mathematical. and computer sciences 

to address this problem collaboratively. 

Reauthorize preterm birth research line (PREEMIE Act, P.L. 109-450) : 

Fmthering CDC's robust research agenda the Foundation proposes expanding 

CDC epidemiological research to include: (1) on the clinical, biological, social, 

genetic and behavioral factors relating to prematurity; (2) to improve national data 

to facilitate tracking the burden of pretenn birth; (3) to develop, implement and 

evaluate novel methods for prevention to better understand the growing problem 

of late preterm birth; (4) to conduct etiologic and epidemiologic studies of 

preterm birth; (5) to expand research on racial and ethnic disparities and (6) the 

effectiveness of community based interventions 

Secretary's Advisory Committee on Infant Mortality: Authorize and amend 

the scope of responsibilities and membership to stimulate more consistent 

collaboration among HHS agencies and to better target resources to support 

promising research activities conducted under the auspices of various federal 

agencies. 

Education Demonstration Projects: Authorize funding for the Health Resources 

and Services Administration to award demonstration project grants for the 

purpose of improving the dissemination of information on prematurity to health 

professionals and other health care providers and to the public. 

Demonstration Projects 

Utilizing the new mandatory Prevention and Public Health Fund created by the Patient 

Protection and Affordable Care Act (P.L. 111-148) the Foundation encourages Congress 

and the Administration to appropriate funding for evidence based initiatives such as the 

Ohio Better Birth Outcomes, the Kentucky Project, or other matemity care models 

designed to reduce the rate of pretenn birth. These initiatives are innovative and may 

dramatically change the delivery of care and support services for pregnant women. 

Moreover, according to a recent report released by the National Center for Health 

Statistics the pretenn birth rate decreased by 5.3% in Ohio from 2006-2008. The 

Foundation believes this decrease is due to the collaborative efforts in this State. It is 

therefore critical to continue this important work and more broadly disseminate the 

information about this and other collaboratives to continue the trend to further decrease 

preterm birth rates. The March of Dimes would be happy to playa role in disseminating 
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the infonnation about these collaboratives and to update you periodically on our other 

efforts to reduce the incidence of pretenn birth. 

Again. thank you for your interest in this topic and for the opportunity to respond to your 

question. Please know that March of Dimes volunteers and staff look forward to working 

with you to accelerate the nation' s efforts to solve this very serious problem. 

Sincerely. 

Alan R. Fleischman. M.D. 

Senior Vice President and Medical Director 

o