Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial (UP Trial)
Phase: NA
Conditions: Uncomplicated Pregnancy, Abnormal Fetal Growth or Fluid
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
 
 
 
 
 
 
 
 
Determination of Abnormal Fetal Growth or Amniotic Fluid with Third Trimester 
Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial (UP Trial) 
 
NCT02702999 
 
Version Date: 05/03/2016 
 
 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
 
 
Determination of Abnormal Fetal Growth or Amniotic Fluid with Third Trimester 
Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial (UP Trial) 
 
 
 
 
Protocol 
 
 
 
 
INVESTIGATORS Principal 
Investigator: Olaide Ashimi 
Balogun, MD 
 
 
 
Co-investigators: 
Robyn Roberts, MD 
Maria Hutchinson, MS 
Hector Mendez-Figueroa, MD 
Suneet P. Chauhan, MD Baha 
M. Sibai, MD 
 
 
 
Department of Obstetrics, Gynecology, and Reproductive Sciences, Division of Maternal-Fetal 
Medicine, University of Texas at Houston Health Science Center 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
PICO Question: 
 
P: Women with uncomplicated pregnancies in the third trimester (30 weeks or more) 
 
I: Ultrasound to assess fetal growth and amniotic fluid every 4 weeks, starting at 30 weeks. 
C: Uncomplicated pregnancies who have clinically indicated obstetric ultrasound 
O: Ultrasound diagnosis of abnormal growth or of abnormal amniotic fluid after 30 weeks. 
 
 
 
 
1 Background 
 
1.1 Abnormal Fetal Growth or Amniotic Fluid in 3rd Trimester 
 
Abnormal fetal growth is defined as an estimate of less than 10% (fetal growth restriction; FGR) 
or greater than 90% (excessive growth) for gestational age. Amniotic fluid is considered to be 
low (oligohydramnios) if the single deepest vertical pocket is less than 2 cm or if amniotic fluid 
index is less than 5.0 cm, and it is regarded as being excessive (polyhydramnios) if the single 
deepest vertical pocket is greater than 8 cm or if the amniotic fluid index is >  24 cm. The reason 
for accurately identifying these 4 conditions is that they are linked with adverse pregnancy 
outcomes, also known as peripartum complications. FGR, for example, is associated with 
stillbirth, cesarean for non-reassuring fetal heart rate tracing, neonatal seizure, sepsis, and 
neonatal death. Excessive fetal growth, also known as large for gestational age (LGA), or 
macrosomia, is associated with prolonged labor, cesarean delivery, traumatic birth, neurologic 
injury and death. Oligohydramnios is associated with stillbirth, emergency cesarean delivery, 
low Apgar score, and fetal anomalies. Lastly, polyhydramnios is associated with abruption, 
stillbirth, and postpartum hemorrhage (Table 1). 
 
To minimize the complications with these four conditions, clinicians in the 3rd trimester have to 
identify these pregnancies, start antepartum surveillance, and time the delivery based on 
gestational age and the results of surveillance (Table 1). 
 
Table 1. Abnormalities of fetal growth or of amniotic fluid 
 
Abnormalities of fetal growth 
Abnormalities of amniotic fluid 
FGR 
LGA 
Oligohydramnios Polyhydramnios 
Definition 
Birth weight < 
10% for GA 
Birth weight 
> the 90% 
for GA 
SDP <2.0 cm or 
AFI< 5.0 cm 
SDP  > 8 cm or 
AFI >  24.0 cm 
Rate in US 
10% 
10% 
3% 
7% 
Increased risk of 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
 
Abnormalities of fetal growth 
Abnormalities of amniotic fluid 
FGR 
LGA 
Oligohydramnios Polyhydramnios 
Stillbirths 
Yes 
-- 
Yes 
Yes 
CD—NR FHRT 
Yes 
-- 
Yes 
Yes 
Traumatic birth 
-- 
Yes 
-- 
-- 
Neonatal seizure 
Yes 
-- 
-- 
-- 
Intubation 
Yes 
-- 
-- 
-- 
Neonatal death 
Yes 
Yes 
Yes 
Yes 
Intervention to improve 
outcomes 
NST / AF assessment 
Yes 
-- 
Yes 
Yes 
Umbilical Doppler 
Yes 
-- 
-- 
-- 
Serial US for growth 
Yes 
Yes 
Yes 
Yes 
Induction at 37-39 wks 
or earlier 
Yes 
Yes 
Yes 
Yes 
Scheduled cesarean 
Yes 
Yes 
-- 
-- 
Considered identified if 
EFW < 10% 
EFW > 90% 
SDP <2.0 cm or 
AFI< 5.0 cm 
SDP  >8.0 cm or 
AFI> 24.0 cm 
Identified in published 
reports 
10-50% (11-17) 
10% (18) 
1% (20) 
3% (20) 
FGR, fetal growth restriction; LGA, large for gestational age; SDP, single deepest pocket; AFI, 
amniotic fluid index (summation of four SDP); CD-NR FHR, cesarean delivery for non-reassuring 
fetal heart rate tracing; EFW, estimated fetal weight 
 
1.2 Current Methods of Detecting Abnormal Fetal Growth or Amniotic Fluid 
 
The current guidelines by American College of Obstetricians and Gynecologists (ACOG) indicate 
that women without complications or co-morbidities should have their fundal height measured 
at prenatal visits. If the difference between fundal height and gestational age is 3 or more then 
ultrasound exam (USE) consisting of fetal growth and assessment of amniotic fluid should be 
undertaken (7). 
 
When performing USE based on indications the detection of abnormal growth is poor because 
majority are undetected. A summary of 7 publications from 6 countries indicates that only 1 out 
of 3 FGR infants were identified before birth (Table 2). Similarly, Heywood et al reported that at 
a  teaching  hospital,  only  11%  of  newborns  with  excessive  growth  were  identified  before 
delivery. Alternatively if ultrasound exam is done within 4 weeks of delivery, then over 60% of 
abnormal growth is identified (19). A recent multi-center pilot randomized trial among 
uncomplicated pregnancies noted that with USE in the 3rd trimester, 67% of FGR were identified 
during pregnancy compared to 9% with routine care; 80% of LGA were identified with USE 
compared to 0% with routine care (20). Thus, a randomized trial is warranted to assess if serial 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
USE after 30 weeks, when compared to current routine care, increases the identification of 
abnormal conditions before birth. 
 
Table 2. Antepartum detection of small for gestational age 
 
Published in 
Country 
Births 
FGR Detected 
Jahn A et al (12) 
1998 
Germany 
2,339 
32% 
Lindqvist PG et al 
(13) 
2005 
Sweden 
24,585 
54% 
McCowan LM et al 
(14) 
2010 
Aus, NZ, UK 
5,606 
27% 
Mattioli KP et al (15) 
2010 
USA 
1,502 
10% 
Verlijsdonk JW et al 
(16) 
2012 
Netherlands 
4,247 
37% 
Chauhan SP et al 
(17) 
2013 
USA 
11,487 
25% 
Monier I et al (18) 
2015 
France 
14,100 
22% 
Total 
63,926 
31% 
Aus, Australia; NZ, New Zeeland, UK, United Kingdom, USA, United States of America 
 
 
 
 
 
2 Study Design 
 
2.1 Primary Research Question 
 
The primary research question is: In women at a gestational age of 30 weeks or more without 
comorbidities, does performance of serial 3rd trimester growth ultrasounds increase the 
frequency of identifying abnormalities in estimate of fetal growth (< 10% or > 90% for 
gestational age) or amniotic fluid (oligohydramnios or polyhydramnios), when compared with 
women who only receive indicated ultrasounds? 
 
 
 
 
2.2 Secondary Research Questions 
 
 Among women with abnormal growth identified on ultrasound, what is the rate of 
newborns with a birth weight < 10% or > 90% for gestational age? 
 What is the composite neonatal morbidity among (CNM; defined below) among women 
with serial versus indicated USE? CNM is any of the following: 1) Apgar score < 5 at 5 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
min, 2) umbilical arterial pH < 7.00, 3) intraventricular hemorrhage grade III or IV, 4) 
periventricular leukomalacia, 5) intubation for over 24 hrs, 6) necrotizing enterocolitis 
grade 2 or 3, 7) stillbirth or 8) death within 28 days of birth. 
 
(Intraventricular hemorrhage was classified by Papile’s criteriawith grade III hemorrhage 
being associated with ventricular dilatation and grade IV with parenchymal extension. 
Necrotizing enterocolitis was diagnosed in the presence of more than one clinical sign, such 
as bilious gastric aspirate or emesis, abdominal distention, occult or gross fecal blood, and 
at least one radiographic finding of pneumatosis intestinalis, hepatobiliary gas, or 
pneumoperitoneum.) (24) 
 
 
 
 What is the composite maternal morbidity (CMM) among those with serial vs indicated 
USE? CMM is defined as any of the following: 1) chorioamnionitis, 2) cesarean delivery 
in labor, 3) wound infection, 4) transfusion, 5) deep venous thrombus or pulmonary 
embolism, 6) admission to intensive care unit or 7) death. 
 
(Chorioamnionitis defined as clinical findings of maternal fever, and maternal and fetal 
tachycardia in the absence of other localizing signs of infection. Wound infection defined as 
tenderness, erythema, or discharge associated with cesarean skin incision.) (26 &27) 
 
2.3 Design Summary 
 
This is a randomized clinical trial, comparing the frequency of identification of abnormal growth 
and / or amniotic fluid among low risk women who either have serial USE vs. those who have 
clinically indicated USE. Women will be randomized to one of two groups: 
 
 Group 1: routine third trimester care with clinically-indicated ultrasound (control) 
 Group  2:  ultrasound  evaluation  for  fetal  growth  and  amniotic  fluid  every  4  weeks 
starting at 30 weeks (intervention group). Thus, if they continue to term, there will be 3 
additional ultrasounds exams (30, 34 and 38 weeks). 
 
 
 
Eligible subjects who meet inclusion/exclusion criteria will be randomized in a 1:1 ratio using 
permuted block randomization in order to prevent imbalances between groups. 
 
2.4 Sample Size Calculation 
 
The definition of the primary outcome is presence of SGA (EFW<10%), LGA (EFW>10%), 
oligohydramnios, or polyhydramnios and is not based on any outcomes after birth. 
 
The estimate for the primary outcome is based on the following assumptions: 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
 In uncomplicated pregnancies, the likelihood of identifying abnormal growth or amniotic 
fluid is 10% in the control group. 
 In  the  intervention  group,  we  hypothesize  the  likelihood  of  detecting  abnormal 
condition to be 25%. 
 To  detect an  increase in  the primary outcome from 10% in  control to  25% in  the 
intervention group with 80% power and alpha of 0.05, a total of 194 (97 in each arm) 
women need to be randomized. 
 We estimate that 5% of patients will be lost to follow up based on a previous pilot study 
(21). The total sample size will be 206 women (103 /group) to allow for loss to follow- 
up. 
 
2.5 Eligibility Criteria 
 
2.5.1 Inclusion Criteria 
 
1.   Maternal age of 18 at the time of consent 
2. Singleton gestation 
2.5.2 Exclusion Criteria 
1.   First sonographic examination after 20 weeks 
2.   Women with any of the following co-morbidities: 
a.  Autoimmune disorders (antiphospholipid 
antibody, lupus, rheumatoid arthritis, scleroderma) 
b. Cerclage in the index pregnancy 
c. Diabetes mellitus—gestational or pre-gestational 
d. Hematologic     disorders     (coagulation      defects,     sickle     cell      disease, 
thrombocytopenia, thrombophilia) 
e. Hypertension (chronic or pregnancy induced) before enrollment 
f.  HIV (human immunodeficiency virus) 
g. Institutionalized individuals (prisoners) 
h. Prior obstetric history of: 1) intrauterine growth restriction, 2) preterm birth 
before 34 weeks, 3) severe preeclampsia, eclampsia, HELLP syndrome, and 4) 
stillbirth after 24 weeks or neonatal death 
i.  Preterm labor or ruptured membranes before enrollment 
j.  Psychiatric disorder (bipolar, depression) on medication 
k. Placenta previa / 3rd trimester bleeding 
l.  Renal insufficiency (serum creatinine > 1.5 mg/dL) 
m. Restrictive lung disease 
n. Fetal red blood cell isoimmunization 
o. Seizure disorder on medication 
p. Thyroid disease on medication 
q. Body Mass Index (BMI) above 40 kg/m2 
3. Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, 
cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
4.   Unable to understand consent in English or Spanish 
 
2.5   Informed Consent Criteria 
Written informed consent must be obtained before entry into the study. Full disclosure of the 
nature and potential risks of participating in the trial is to be made. A copy of the signed 
consent form for the study will be provided to the patient. 
 
Women randomized to the intervention group will not be charged for ultrasound exams which 
are part of the study design. The departmental funds will pay for these exams. If ultrasound 
abnormalities are noted (e.g. abnormality of the fluid or growth) subsequent ultrasound exams 
are needed, according to American College of Obstetricians and Gynecology (ACOG) guidelines 
(Table 3). For these indicated ultrasound exams the insurance company will be billed and these 
exams are not covered by the departmental funds. 
 
Among women in the control arm, the ultrasound exams will be done only when indicated 
according to the ACOG guidelines. Some of the common indications for USE include: 1) 
difference in GA and fundal height > 3 cm; 2) new onset hypertension; 3) decreased fetal 
movement; 4) spotting/ bleeding; 5) preterm premature rupture of membranes, 6) preterm 
labor; 7) maternal trauma. Since these exams are indicated, the charges will be submitted to 
the appropriate insurance company. 
 
 
 
2.6   Projected study sites 
 
1. UT Physicians Women’s Center-Texas Medical Center 
2. UT Physicians Women’s Center-Bellaire 
 
 
 
3.1 Methods 
3 Study Procedures 
 
After gestational diabetes is ruled out, usually by 28-30 weeks, and the woman is confirmed to 
meet  the  eligibility  criteria,  she  will  be  approached  for  participation.  Patients  will  be 
randomized using the random permuted block randomization method using allocation tables 
created by a statistician. The sonographic examination will be done by a registered diagnostic 
medical sonographer (RDMS). 
 
The examinations will be done after the prenatal visits and there will be no charges for the 
ultrasound. No economic burden will be imposed on participants. Consistent with the ACOG 
recommendations that the sonographic exams be repeated every 4 weeks, we will repeat the 
exams every 4 weeks. Thus, if a women is recruited at 30 weeks, she will have sonographic 
examination at 30, 34 and at 38 weeks. If a woman develops obstetric complications, such as 
preterm labor or hypertensive disease of pregnancy, which requires sonographic examination 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
she will have exams by RDMS but based on intent-to-treat principle continue to be in the group 
she is randomized to. Clinicians managing the women will be informed of the findings of the 
USE. 
 
The third trimester ultrasounds will follow the American Institute of Ultrasound in Medicine 
(2007) guidelines. In particular, biparietal diameter (BPD) will be measured at the level of 
thalami and insula, and measurement taken from outer edge of the proximal skull to the inner 
edge of the distal skull. The head circumference (HC) will be measured at the same level as the 
biparietal diameter, around the outer perimeter of the calvaria. Since HC is not affected by 
head shape, it will be used if the head is flattened (dolichocephaly) or rounded (brachycephaly). 
Abdominal circumference (AC) measurement will be determined at the skin line on a true 
transverse view at the level of the junction of the umbilical vein, portal sinus and the fetal 
stomach.   Femoral   length   (FL)   will   be   measured   with   the   beam   of   insonation   being 
perpendicular to  the  shaft,  excluding the  distal  femoral epiphysis (Chervenak 1998, ACOG 
2009).  Estimated  fetal  weight  will  be  derived  using  the  regression  equation  proposed  by 
Hadlock  (1985): Log10   (EFW)  =  1.5662 – 0.0108(HC) +  0.0034(HC)2  + 0.0468(AC)+0.171(FL)- 
0.003685(AC)(FL) with EFW being estimated fetal weight; HC, head circumference; AC, 
abdominal circumference, and; FL, femur length. If a fetal anomaly which was not noted in early 
survey is discovered during the 3rd trimester USE, clinicians and women be informed. 
 
Abnormalities of fetal growth are fetal growth restriction (FGR) and large for gestational age 
(LGA). A fetus will be considered to have FGR if the estimated fetal weight is < 10% for 
gestational age and LGA if the estimate is > 90% for gestational age. Amniotic fluid will be 
estimated using single sonographic deepest pocket (SDP), which involves finding and vertically 
measuring the largest cord-free pocket of amniotic fluid or will be calculated by the sum of the 
maximum vertical pockets in all 4 quadrants. Oligohydramnios, or decreased amniotic volume, 
is a SDP less than 2 cm or amniotic fluid index < 5.0 cm; hydramnios, or excessive amniotic fluid, 
is a SDP >8 cm or amniotic fluid > 24.0 cm(ACOG 2009). 
 
3.2 Baseline Procedures 
 
In addition to information for eligibility, project gestational age, the following variables will be 
collected from the patient’s chart. 
 
 Demographics (maternal age, race, ethnicity) 
 Medical history (obstetrical history, body mass index pre-pregnancy and at delivery, 
maternal comorbidities) 
 Ultrasound information (fetal growth and amniotic fluid measurements) 
 Delivery characteristics 
 Timing of delivery 
 Neonatal outcomes while hospitalized 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
 
 
3.3 Patient Management 
 
Clinicians managing these women will be informed of the sonographic findings if any of the 
following is noted: 1) FGR or estimated fetal weight < 10% for gestational age, 2) LGA or 
estimated fetal weight > 90% for gestational age, 3) oligohydramnios, 4) hydramnios, or 5) 
sonographic findings which influences clinical management e.g. spontaneous bradycardia or 
previously undetected fetal anomaly. Women with abnormal findings will be notified. They will 
also  be  informed  that  their  clinicians  are  aware  and  management  will  be  according  to 
guidelines and departmental practices (Table 3). 
 
 
 
 
Table 3. Abnormal findings and recommendation to clinicians 
 
Abnormalities seen on 
Ultrasound 
Recommendation to Clinicians 
FGR  (estimated  fetal  weight  < 
10% 
for 
GA)—from 
ACOG 
Practice Bulletin # 134 (reference 
7) 
 
Unless   previously   done,   perform   a   detailed   fetal 
anatomic survey 
 
Serial ultrasound evaluations of the following: 
(1) Fetal growth with Doppler 
velocimetry (every 3- 4 weeks) 
(2) Biophysical profile with or without non-stress 
test (weekly) along with umbilical artery Dopplers 
 
One course of antenatal corticosteroids between 24 and 
34  weeks  of  gestation  in  the  week  before  delivery  is 
expected 
 
Delivery at 38-39 weeks or sooner if abnormal results of 
antepartum testing or co- 
LGA  (estimated  fetal  weight)— 
from ACOG Practice Bulletin # 22 
(reference 22) 
 
If EFW is > 5,000 in non-diabetic, recommend primary 
cesarean delivery 
1. Oligohydramnios—from 
ACOG Practice Bulletin # 145 
(reference 2) 
 
Consider  a  repeat  fetal  structural  survey  to  rule  out 
possible missed a fetal malformation 
 
Non-stress  test  (NST)  and  AFI  (or  biophysical  profile) 
once or twice weekly until delivery 
 
For women with idiopathic oligohydramnios, we suggest 
delivery at 36 to 37 completed weeks of gestation rather 
than expectant management 
Polyhdyramnios—(reference 23) 
 
A   repeat   comprehensive   sonographic   evaluation   is 
recommended to determine whether fetal anomalies or 
fetal hydrops is present. 
 
Suggested 
laboratory 
evaluations 
depend 
upon 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
 
Abnormalities seen on 
Ultrasound 
Recommendation to Clinicians 
sonographic   findings   and   may   include   testing   for 
karyotype analysis, fetomaternal hemorrhage if fetal 
anemia is suspected, maternal serology to determine 
exposure to infectious agents (eg, syphilis, parvovirus, 
cytomegalovirus,  toxoplasmosis,  rubella),  and 
appropriate tests for hereditary anemias (eg, alpha 
thalassemia) or metabolic abnormalities. 
 
We suggest treatment for polyhydramnios in singleton 
pregnancy only if there is preterm labor or significant 
maternal discomfort with amnioreduction. 
Undetected fetal anomaly 
 
A repeat detailed sonographic evaluation 
 
Recommend offering karyotype analysis in if knowledge 
of the karyotype will affect management 
Spontaneous Bradycardia 
 
Prolonged fetal monitoring on labor and delivery triage 
unit 
 
 
 
3.4 Study Outcome Measures and Ascertainments 
 
 
3.4.1    Primary outcome: 
 
The primary outcome is presence of SGA (EFW<10%), LGA (EFW>10%), oligohydramnios, or 
polyhydramnios among uncomplicated pregnancies that have indicated versus serial USE 
starting at 30 weeks or more. These parameters are not based on any outcomes after birth. 
 
3.4.2 Secondary outcomes: 
 
 Composite Neonatal Morbidity (CNM) among the two groups 
 Composite Maternal Morbidity (CMM) among the two groups. 
 
3.4.3 Statistical Analysis 
 
Intention to treat analyses will be performed. The rate of the primary outcome, abnormal fetal 
condition (estimated fetal weight < 10% or > 90% for GA, oligohydramnios or polyhydramnios) , 
will be compared between the intervention and control group using a log binomial (or Poisson 
in case of nonconvergence) model with treatment group as a covariate to estimate relative risk 
and 95% confidence interval (CI). The definition of the primary outcome is presence of FGR 
(EFW<10%), LGA (EFW>90%), oligohydramnios, or polyhydramnios and is not based on any 
outcomes after birth. Therefore there is no issue about false-positives or false-negatives. 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
Each secondary outcome will be analyzed similarly. Based on the MFMU Network data that 
stated CNM occurs in 1.9% of women with uncomplicated pregnancies, we estimate that over 
29,000 women need to be randomized to show one-third improvement in CNM (power 90%) 
among  uncomplicated  women  that  have  routine  ultrasound  exams  vs.  those  that  have 
indicated ultrasound examinations. Hence our purpose for these outcomes is to calculate 
unbiased estimates to provide information for the large multicenter trial in MFMU Network. 
 
We will also conduct a Bayesian analysis of the primary outcome to calculate probability of 
treatment benefit or harm. We will use a neutral prior distribution for the intervention effect 
that excludes implausible large treatment effects: Normal (0, SD=0.70) in the log RR scale (prior 
95% interval for the RR of 0.23-4.35) (28) Point estimates of treatment effect and 95% credible 
intervals will be reported with posterior probabilities of benefit and/or harm. 
 
 
 
 
 
 
 
 
 
4 Ethics 
 
4.1 IRB approval 
 
IRB approval will be obtained through the Committee for Protection of Human Subjects (CPHS) 
prior to initiation of the study. 
 
4.2 Consent process 
 
We will have patients sign an informed written consent at the beginning of the study. 
 
4.3 PHI 
 
The MRN of the mother and the newborn will be kept on a separate list paired with a study ID 
number.  The MRN will be maintained to track neonatal outcomes, which will not be readily 
available at the time of delivery.  This database will be password protected and located on a 
folder within the UT server which will only be accessed by the principal investigator. 
 
4.4 Data Handling and Record Keeping 
 
The data for this study will be recorded on a spreadsheet that will be stored on computers in 
the medical school which are password protected and located in a locked office.  A master list 
containing study ID linked with MRN will be maintained on these same computers.  The MRN 
will be stored solely to track neonatal outcomes.  The list will be discarded at the end of the 
study. 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
 
 
5 Quality Assurances 
 
5.1 Data collection 
 
Data will be collected on premade data sheets (see attachment) by either the principal 
investigators or Maternal-Fetal Medicine fellows. 
 
 
 
 
5.2 Publication Plans 
 
The study will be listed in the public database on clinical studies www.clinicaltrials.gov.  A 
summary report of the study will be made available after the conclusion of the study. It is the 
intention to publish the results of this study in a peer-reviewed journal. 
 
 
 
 
 
 
6 Financial Disclosure 
 
6.1 
 
All  rules  and  regulations  on  the  documentation  and  disclosure  of  any  potential  financial 
conflicts will be adhered to. 

IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016 
 
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IRB NUMBER: HSC-MS-16-0084 
IRB APPROVAL DATE: 05/03/2016