Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Phase: NA
Conditions: Contraception, Breastfeeding, Postpartum Contraception
Sponsor: Montefiore Medical Center

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Title: Immediate postpartum contraceptive implant placement and breastfeeding 
success in women at risk for low milk supply: a randomized non-inferiority trial
Principal Investigator: 
Antoinette A. Danvers, 
MD MBA MSCR MS
Department of OBGYN & Women’s Health 
1695 Eastchester Rd. Suite 306, Bronx, NY 10461
Email: adanvers@montefiore.org 
Co-Investigators: 
Molly Findley, DO, MPH
Phone: 718-405-8200; Fax: (718) 405-8016
Email: mfindley@montefiore.org
Jessica Atrio
Phone: 718-405-8200; Fax: (718) 405-8016
Email: jatrio@montefiore.org
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Abstract:
Immediate postpartum initiation of the etonogestrel contraceptive implant has been 
proven to decrease rates of rapid, repeat pregnancies. Evidence supports that in healthy 
women with term infants initiation of the contraceptive implant 1-3 days postpartum does 
not appear to have any adverse effects on lactogenesis or breastfeeding continuation.
However, no high quality study to date has examined the effects of progestin-only 
contraception in women known to be at risk for low milk supply, including women with a 
premature delivery, obesity, polycystic ovarian syndrome, diabetes, or a prior history of 
low milk supply.
Our goal is to measure the impact of timing of postpartum contraceptive implant insertion 
on breastfeeding success and duration. This will be a three-armed randomized non- 
inferiority study of women who plan to breastfeed, have known risk factors for low milk 
supply, and who intend to use the contraceptive implant postpartum. Women will be 
randomized to one of three groups for the timing of contraceptive implant placement: 
within 30 minutes of placental delivery, 24-72 hours postpartum, or 6 or more weeks 
postpartum. Women will be assessed at 6 weeks, 3 months and 6 months postpartum.
Outcomes will include time to lactogenesis II, duration and exclusivity of breastfeeding, 
continuation of and satisfaction with the contraceptive implant, and side effects, including 
bleeding patterns, associated with the implant.
Findings from this trial will be used by clinicians, hospital systems, and policy makers 
working to expand access to immediate postpartum implants while supporting women in 
meeting their breastfeeding goals.
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Specific Aims
Our goal is to measure the impact of timing of postpartum contraceptive implant insertion 
on breastfeeding success and duration and to explore women’s experiences with and 
attitudes towards contraceptive and breastfeeding counseling in the peripartum time 
period.
Specific Aim 1: To compare time to lactogenesis stage II among women randomized to 
receive the contraceptive implant within 30 minutes postpartum, 1-3 days postpartum 
and 6 or more weeks postpartum, utilizing a validated measure
Specific Aim 2: To assess rates of breastfeeding continuation, exclusivity, and 
satisfaction as well as device continuation and method satisfaction at 6 months 
postpartum among women who were randomized to receive the contraceptive implant 
within 30 minutes postpartum, 1-3 days postpartum and 6 or more weeks postpartum, 
utilizing a validated measure
Rationale
Immediate postpartum initiation of the etonogestrel contraceptive implant has been 
proven to decrease rates of rapid, repeat pregnancies1. Evidence supports that in 
healthy women with term infants initiation of the contraceptive implant 1-3 days 
postpartum does not appear to have any adverse effects on lactogenesis or 
breastfeeding continuation2. However, no high quality study to date has examined the 
effects of progestin-only contraception in women known to be at risk for low milk supply, 
including women with a premature delivery, obesity, polycystic ovarian syndrome, 
diabetes, or a prior history of low milk supply3,4. Preventing unintended pregnancy in this 
population of women is particularly important, as many of the conditions that put women 
at risk for difficulty with breastfeeding also increase the likelihood of a medically complex 
pregnancy with poorer outcomes for both women and infants. Clinicians, hospital 
systems, and policy makers working to expand access to immediate postpartum 
implants and desiring to support women in meeting their breastfeeding goals need 
quality evidence to guide them when offering immediate postpartum implants to some of 
their most medically complex patients5.
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It is unclear if the specific timing of immediate postpartum implant initiation may have an 
effect on breastfeeding success. Theoretically, exposure to progesterone prior to the 
establishment of lactogenesis may interfere with the successful establishment of a milk 
supply6. In creating work flows to increase access to postpartum implants, placing an 
implant within 30 minutes of delivery may be the most efficient and streamlined option 
for many settings. However, no data exists on the effect of initiating a contraceptive 
implant prior to 1-3 days postpartum on the timing of lactogenesis or breastfeeding 
duration.
Research Design and Methods
Research Design and Study Subjects
This will be a three-armed randomized non-inferiority study of women delivering at the 
Weiler Hospital of the Albert Einstein College of Medicine who plan to breastfeed, have 
known risk factors for low milk supply, and who intend to use the contraceptive implant 
postpartum. Women will be randomized to one of three groups: device placed within 30 
minutes of placental delivery, 24-72 hours postpartum, or 6 or more weeks postpartum. 
All study activities will adhere to the CONSORT guidelines for reporting randomized 
trials.7 Women will be assessed at enrollment, 1-5 days postpartum, 6 weeks, 3 months 
and 6 months postpartum.
Eligibility Criteria will include:
1) Live pregnancy of at least 24 weeks gestation
2) Intention to use a contraceptive implant postpartum
3) Intention to use a non-hormonal bridging method of contraception until a 
contraceptive implant can be placed
4) 18 years of age or older
5) English or Spanish speaking
6) Women will be enrolled either during prenatal care or upon admission to Labor 
and Delivery.
7) Absence of pain. Among women who are being enrolled on Labor and 
Delivery MUST fall into one of the three following categories:

Women presenting for induction of labor. Women will be approached and 
enrolled prior to the onset of labor.

Women presenting for a planned cesarean delivery. Women will be 
approached and enrolled prior to entry into the operating room.
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
Women who have an Epidural in place for management of pain. Prior to 
engaging in a discussion regarding the study protocol, women will be 
asked of they are experiencing any pain, and if the answer is yes, they 
will not be eligible for entry into the study.
7) Presence of at least one of the following conditions known to be a risk factor 
for low milk supply:

Expected delivery prior to 37 weeks

Obesity (pre-pregnancy BMI >35)

Polycystic Ovarian Syndrome

Diabetes (gestational or pre-gestational)

Self-reported difficulty with low milk supply in past
Setting and Population
Efforts will be made to identify and recruit eligible women during their prenatal at 
outpatient Montefiore Health Centers affiliated with the Weiler Hospital of the Albert 
Einstein College of Medicine in the Bronx, NY. The Bronx is home to the poorest 
congressional district in the country, and the worst healthcare outcomes in New York 
State8. One in three adults in the Bronx is obese9, and in the poorer neighborhoods a full 
61% are either obese, diabetic, or both10. In 2013, there were 4023 deliveries at Weiler 
Hospital, most to poor women of color (Table 1).
Table 1: Demographics of women delivering at Weiler Hospital in 2013
Age
Race
Ethnicity
Insurance Type
<20
7.1%
Black or 
African 
American
31.3%
Hispanic 
or Latina
48.9%
Medicaid and 
Self-Pay
64.7%
20-
30
57.7%
White
11.0%
Non- 
Hispanic 
or Latina
45.9%
Private 
Insurance
35.3%
>30
35.2%
Asian
3.4%
Declined
5.2%
Socioeconomic 
Status
Multiracial
41.5%
Below NYS 
Average
91.2%
Declined
12.8%
Above NYS
Average
8.8%
Since July of 2014 immediate postpartum initiation of LARC devices has been available 
to all medically eligible women at Weiler Hospital. Currently we place approximately 100
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devices, including 60 implants each month. As the tertiary referral center in a vulnerable 
and high-risk community, it is reasonable to estimate that at least 50% of the women 
who deliver at Weiler Hospital have at least one risk factor for low milk supply.
Recruitment
For women who receive prenatal care within the Montefiore system, the recruitment 
process will start during their prenatal visits. It is a routine part of prenatal care for 
women to get contraceptive counseling and education about the benefits of 
breastfeeding. Flyers and brochures advertising the study will be made available to all 
clinical sites providing prenatal care and to all prenatal care providers. Women will have 
the opportunity to review these materials, contact the research team with any questions, 
and review the consent form prior to admission to labor and delivery if they desire.
Women who are interested in enrolling in the study will be identified by prenatal care 
providers and research study staff will call the women and provide information about the 
study. Women will have the opportunity to consent for participation into the study over 
the phone. In these cases, a pop-up message will be created in EPIC to alert the study 
team when this patient present for admission to Labor and Delivery. Once these women 
present to Labor ad Delivery they will also be asked to sign a study consent form and 
reaffirm their desire to participate in the study. They will be randomized into the trial only 
once they present to Labor and Delivery and reaffirm their desire to participate in the 
trial.
It is standard practice at Montefiore to counsel all women on admission to Labor and 
Delivery about their contraceptive options, including immediate postpartum IUDs and 
implants upon admission. This counseling is provided by the admitting resident, PA or 
faculty on Labor and Delivery. The admitting team routinely reviews and documents a 
contraceptive plan and breastfeeding intentions for each woman admitted to labor and 
delivery. The study’s research coordinators will review the patients admitted to Labor 
and Delivery regularly (1-3 times daily) in order to identify women eligible for 
participation in this trial. Only those women who have a documented intention to use a 
contraceptive implant postpartum will be approached by the study team for possible 
enrollment into the trial.
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Women will be enrolled, consented and randomized on Labor and Delivery, prior to 
delivery. The study brochure will be included in the standard educational materials 
provided to all women on admission to Labor and Delivery. All enrollment and screening 
will be done in private labor and delivery rooms and all measures will be taken to ensure 
patient privacy. Women will be explicitly told that their participation in this trial is 
voluntary and that they have the option of receiving a contraceptive implant at any of the 
time points included in this study if they decline participation in this trial. Only co- 
investigators who have completed CITI training and who are intimately familiar with the 
study protocol will be approaching or enrolling patients into the trail.
During the informed consent process, women will receive standardized contraceptive 
counseling, including information about the contraceptive implant and its potential effects 
on breastfeeding. Women who are eligible for the trial and interested in participating will 
be enrolled and randomized in a 1:1:1 ratio to one of the three groups to determine their 
timing of contraceptive implant placement. Participants will be assigned using computer- 
generated random numbers in blocks of varying sizes with strict allocation concealment 
using sequentially numbered opaque envelopes. Women will be informed of their 
randomization group at the time of enrollment into the trial.
Women randomized to receive the implant within 30 minutes of delivery will have the 
implant placed in the delivery room or operating room within 30 minutes of placental 
delivery. Placement of the implant will not interfere with any skin-to-skin interactions that 
are currently routinely encouraged for the mother and infant after every delivery. Women 
randomized to receive the implant within 1-3 days of delivery will have their implant 
placed on the postpartum unit more than 24 hours after delivery, but prior to discharge 
from the hospital. Women randomized to receive the implant at 6 or more weeks 
postpartum will be scheduled for an outpatient visit with the family planning clinic at 6-8 
weeks postpartum for implant placement.
Study Procedures
Follow-up and data collection for participants in all three groups will be identical. In order 
to achieve specific aim 1, time to lactogenesis stage II will be measured based on 
maternal perception based on measures described and validated by Chapman et al12 
and utilized in a similar study by Gurtcheff et al. 2 Beginning on the first postpartum day,
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subjects will be contacted daily. Subjects will be asked, “Has your milk come in? Some 
women experience this as a prickly feeling or tingling in the breast, dripping from the 
other nipple when nursing, milk running from the baby’s mouth, or gulping by the baby. ” 
If the response is positive, women will then be asked, “When did your milk come in?” 
and the response recorded to the nearest hour. If lactogenesis has not occurred prior to 
hospital discharge, the patient will be contacted at least daily by their preferred method 
(phone, text or email) from study personnel until lactogenesis can be confirmed and 
recorded.
To achieve specific aim 2, women will complete study follow-up questionnaires at 6 
weeks, 3 months and 6 months postpartum either by phone interview or by electronic 
web-survey, depending on the participant’s preference.  These questionnaires will 
assess breastfeeding status, exclusivity and satisfaction as well as contraceptive method 
continuation, satisfaction, and side effects, including bleeding. Women will be asked to 
contact the study coordinators when they stop breastfeeding or if they discontinue the 
contraceptive implant.
Recruitment, Follow-up and Retention.
Successful recruitment, follow-up and retention represents the most significant challenge 
to the completion of this project. The population of women we intend to enroll is 
socioeconomically disadvantaged and has high rates of non-adherence to postpartum 
care. Only 43% of women who deliver at Weiler attend a postpartum visit within12 weeks 
of delivery. While this is a difficult to study population, they are also the women who may 
benefit the most from access to immediate postpartum contraception as attendance at a 
postpartum visit clearly represents a significant barrier to care for most of these women. 
Dr. Bonuck has a proven track record of successfully following women in this specific 
community in the immediate postpartum period. She served as the principal investigator 
on a set of trials examining the effects of a primary care intervention on breastfeeding 
outcomes13. During these trials she successfully recruited and followed a cohort of 
postpartum women from our institution and has developed a set of proven strategies for 
ensuring high levels of retention among a population of women with historically high 
attrition rates14. We intend to use the following specific strategies:
1)
Strong Rapport with the Participants
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a)
Research Coordinators (RC) will visit the women enrolled in to the study at least 
twice during their postpartum admission to encourage rapport building
b)
RCs will maintain regular contact with participants throughout the follow up 
period via text and email. Reminders will be emailed and texted in the weeks 
prior to any scheduled follow-up.
c)
RCs will send birthday ECards for all the study participants.
d)
Participants will be provided with business cards and other items (pens, 
magnets) containing the RC cell phone number and study contact information.
2)
Convenience for the Participants
a)
Brief- Upon final pilot testing the follow-up questionnaires will take < 15 minutes 
to complete.
b)
Flexible methods- Participants will have the option of completing the follow-up 
questionnaires via phone or web survey.
c)
Flexible hours- Women will indicate their preferred times to be called, including 
nights and weekends
d)
Bilingual- All written study materials will be available in both English and Spanish. 
The RCs will be bilingual.
3)
Educational and Appropriate Materials and Questionnaires
a)
The interview scripts and questionnaires will be developed to utilize non- 
judgmental language. The scripts and questionnaires will be piloted for content, 
clarity, and appropriateness prior to beginning enrollment.
b)
Educational materials regarding contraceptive options and breastfeeding support 
will be made available to all women participating in the cohort. Study personnel 
will be available to answers women’s questions regarding their breastfeeding and 
contraceptive options.
4)
Strategies for Maximizing Retention
a)
Multiple Contacts- Upon enrollment, we will obtain all potential contact options for 
the woman that she is willing to share (cell and home phone numbers, home 
address, and email), as well as contact information for at least three other 
people.
b)
Research Coordinators will send out texts, emails and postcards to alert 
participants if they were unable to be reached for an interview.
5)
Patient Incentives
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a)
Women will be given $50 at enrollment and $30 for completion of each 
subsequent follow-up questionnaire. Incentives will be disbursed using debit 
cards that allow money to be transferred electronically, allowing the women to 
have access to the money within 24 hours of survey completion. This dollar 
amount is in line with other projects that have had >90% retention over one year 
in our Bronx population.
Sample Size
To achieve specific aim 1, we chose a non-inferiority margin of an additional 8 hours to 
achieve lactogenesis II, as this would be clinically relevant. In order to achieve 80% 
power, using a one-sided Type 1 error of 5%, and with a standard deviation in time to 
lactogenesis of up to 18 hours15,16, 63 women would be needed in each group, for a total 
of 189 women.
To achieve specific aim 2, larger sample size will be required. Prior studies in our 
population have found that breastfeeding continuation rates at 6 months postpartum are 
27%13. Assuming a non-inferiority margin of 15%, to achieve 80% power using a one- 
sided Type 1 error of 5%, we would need to enroll 109 women per group, for a total of 
327 women total. Assuming a 15% loss to follow up rate, we will enroll 375 women total, 
125 in each group. This recruitment goal will be met over an 18 month time period and is 
attainable based on the approximately 60 implants placed each month on the Labor and 
Delivery and Postpartum units.
Risks and Benefits
Answering Questions during Enrollment or at Follow-up: Women may feel uncomfortable 
answering questions about breastfeeding and birth control. Women can choose not to 
answer questions that make them feel uncomfortable. All interviews that are done in the 
hospital setting will be done in a private room (all patient rooms on Labor and Delivery or 
on Postpartum are private), with the door closed. For follow-up, women will be able to 
choose if they complete the questionnaire over the phone, at a time convenient for them, 
or via a web-based HIPPA secure survey generated through REDCaps.
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Insertion of the Implant: Choosing to enroll in this study means that women will be 
assigned to one of three time points for contraceptive implant initiation after delivery, as 
opposed to receiving it at a time of their own choosing. Currently all women delivering at 
Weiler are routinely offered immediate postpartum initiation of the contraceptive implant 
at all the time points being studied as a part of this protocol. Insertion of the implant is a 
very safe procedure with risks comparable to a blood draw or IV placement. Having the 
implant placed as part of this study does not confer any additional or different risk 
associated with the insertion procedure than if the implant was placed at any other time.
Breastfeeding: Currently all available data regarding breastfeeding and the implant 
demonstrate that immediate postpartum initiation of the implant does not have any effect 
on breastfeeding establishment, success, or duration. Prior studies have not specifically 
looked at women who have risk factors for low milk supply, however, the CDC, ACOG, 
and institutional guidelines do support the use of the implants in the immediate 
postpartum period for this population. Currently the routine practice at Montefiore is that 
all women are offered immediate postpartum placement of a contraceptive implant. All 
women are counseled that current evidence does not demonstrate that the implant 
would have any effect on breastfeeding, but that data is limited, especially for women 
with risk factors for low milk supply. This study does not confer any additional risk to 
breastfeeding women over our current routine practice but will allow those women who 
are enrolled into the trial to have more ready access to providers and community 
resources for breastfeeding support.
Analysis Plan
The following outcomes will be evaluated using T-tests and include: exclusive 
breastfeeding continuation, any breastfeeding continuation, implant continuation. 
Additional secondary outcomes include side effects and tolerability of the implant, 
vaginal bleeding patterns, and contraceptive use. To evaluate these secondary 
outcomes between the two groups we will use the T-test, Wilcoxon Rank Sum test, Chi- 
squared test, or Fisher’s exact test as appropriate.
Data and Safety Monitoring
Patient safety will be monitored continuously by the research team. Given that each of 
the study interventions is currently considered standard of care at Montefiore, a Data
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Safety Monitoring Board is not needed for this trial. The principal investigator and 
research team will actively review all outcomes for the patients throughout the course of 
the study, and identify potential adverse events experienced by study participants and 
report them to the IRB as required by local standards. The PI will be responsible for 
reviewing these reports and making the final determination of relatedness, reporting to 
the IRB, and taking relevant actions as needed.
Adverse Event
An adverse event (AE) is any symptom, sign, illness or experience that develops or 
worsens in severity during the course of the study.
A number of adverse events are expected in the course of the management of labor and 
postpartum including: pain, bleeding, fevers, chills, nausea, vomiting, diarrhea, 
dizziness, and endometritis. The only non-serious events that will be specifically 
collected by the research-team and classified as AEs for this study are those that are 
both unexpected and considered to be related to study procedures or study drug.
All adverse events will be collected, recorded, and assessed locally by the PI or 
research-team. Events that are determined to be both unexpected and related to the 
study will be reported and reviewed.
Serious Adverse Event
Adverse events are classified as serious or non-serious. A serious adverse event is 
any AE that is:

fatal

life-threatening

requires or prolongs hospital stay

results in persistent or significant disability or incapacity

a congenital anomaly or birth defect

an important medical event
Important medical events are those that may not be immediately life threatening, but are 
clearly of major clinical significance. They may jeopardize the subject, and may require 
intervention to prevent one of the other serious outcomes noted above.
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All serious adverse events will be reported to the principal investigator.
Adverse Event Reporting Instructions
Any serious adverse event whether or not it is considered related to the study, will be 
reported by telephone, email or fax within 24 hours of awareness to principal 
investigator:
Antoinette A. Danvers Email: adanvers@montefiore.org
The investigator will compile a serious adverse event form and the case will be 
discussed within 48 hours with the study team. A SAE form will be completed for any 
SAE that is experienced after the subject has signed the Informed Consent Form.
The Principal Investigator will submit updated SAE. The Principal Investigator will 
evaluate women who experience a SAE as necessary until the event is resolved.
The principal investigator will report adverse events for review by the IRB per local 
reporting requirements.
Adverse Event Reporting Period
The study period during which adverse events must be reported is normally defined as 
the period from the initiation of any study procedures to the end of the study treatment 
follow-up. For this study, the study treatment follow-up is defined as 6 months 
postpartum.
Post-study Adverse Event
All unresolved adverse events should be followed by the investigator until the events are 
resolved, the subject is lost to follow-up, or the adverse event is otherwise explained.
Before discharge, the investigator should instruct each subject to report any subsequent 
event(s) that the subject, or the subject’s personal physician, believes might reasonably 
be related to participation in this study.
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Study Stopping Rules
If more than 30% of women in any study group have primary lactation failure and are 
unable to achieve lactogenesis the study will be temporarily stopped and the data 
reviewed to determine if it reasonable to continue the study.
Data Quality
Personnel Selection and Training
The primary investigator and the research team will be responsible to complete the 
monitoring process as these individuals have experience in the conduct of clinical 
research and familiarity with research regulations. Furthermore, they are well aware of 
safety and adverse event review and reporting, the study protocol, the study database, 
the informed consent forms and processes and this monitoring plan.
Frequency
Enrollment will be complete when 375 subjects are enrolled into the trial. Approximately 
25 subjects will be enrolled per month. The research team will review the study database 
and cross check to the medical record for accuracy. Quality assurance will be conducted 
periodically throughout the study as described below:

The first time-point of review will occur after the first 5 subjects have been enrolled.

If no issues of concern are noted, subsequent quality monitoring will occur at least 
every 6 months by 2 persons on the research team. All findings will be discussed with 
primary investigator and any concerns will be shared with members of the safety 
monitoring board.

The final point of review will be conducted when 100% of the subjects have been 
enrolled and completed the study.
Additional quality data check may occur on an as-needed basis as determined by the 
principal investigator.
Data Quality Checks
All database entries for all the subjects at each site will be source data verified. Special 
attention will be given to the following variables and will be 100% source data verified for 
all subjects enrolled in the study.
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
Informed Consent

Inclusion/Exclusion Criteria

Serious Adverse Events

Primary Outcomes/Endpoint Data Verification
Data Management
REDCap (Research Electronic Data Capture) is a secure web application for building 
and managing online surveys and databases. We will use REDCap software to create 
data collection forms, generate HIPPA secure web links to the follow-up questionnaire, 
complete double data entry and manage all data from the study. Only the research 
coordinators and investigators will have access to the study charts and to the REDCaps 
database.
Study Close Out
The principal investigator and research team will conduct the study close out at the time 
of the final within 3 months after the last patient has completed the study.
The following activities will be completed by the PI to close out the study:

Ensure all data has been reviewed and collected;

Ensure all outstanding queries are answered;

Confirm all Serious Adverse Events, if applicable, have been reported to the IRB(s) 
and the FDA;

Ensure all protocol violations were submitted to the IRB per local requirements;

Ensure that all continuing review reports were submitted to the IRB.
Links with Other Projects
Montefiore is part of the New York City Department of Health and Mental Hygiene’s 
consortium for Quality Improvement Network for Contraceptive Access17. Participation in 
this consortium is an opportunity for hospitals to get support and technical assistance to 
increase their access to contraception and LARC. Montefiore is a leader in the region, 
and through this consortium our policies and procedures have been made available to 
other hospitals seeking to increase contraceptive access. The results of our proposed
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study will inform local hospital policies and city initiatives that support breastfeeding 
while increasing LARC access postpartum.
Expected Outcomes
The findings from this study will inform clinical practice, national guidelines and policies 
regarding postpartum use of the etonogestrel contraceptive implant and breastfeeding 
safety for women at risk for low milk supply.
References
1.
Tocce KM, Sheeder JL, Teal SB. Rapid repeat pregnancy in adolescents: do 
immediate postpartum contraceptive implants make a difference? American 
journal of obstetrics and gynecology. Jun 2012;206(6):481 e481-487.
2.
Gurtcheff SE, Turok DK, Stoddard G, Murphy PA, Gibson M, Jones KP. 
Lactogenesis after early postpartum use of the contraceptive implant: a 
randomized controlled trial. Obstetrics and gynecology. May 2011;117(5):1114- 
1121.
3.
Lopez LM, Grey TW, Stuebe AM, Chen M, Truitt ST, Gallo MF. Combined 
hormonal versus nonhormonal versus progestin-only contraception in lactation. 
Cochrane Database Syst Rev. 2015;3:CD003988.
4.
Phillips SJ, Tepper NK, Kapp N, Nanda K, Temmerman M, Curtis KM. 
Progestogen-only contraceptive use among breastfeeding women: a systematic 
review. Contraception. Sep 26 2015.
5.
Berens P, Labbok M, Academy of Breastfeeding M. ABM Clinical Protocol #13: 
Contraception During Breastfeeding, Revised 2015. Breastfeed Med. Jan-Feb 
2015;10(1):3-12.
6.
Neifert MR, McDonough SL, Neville MC. Failure of lactogenesis associated with 
placental retention. American journal of obstetrics and gynecology. Jun 15 
1981;140(4):477-478.
7.
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated 
guidelines for reporting parallel group randomised trials. Trials. 2010;11:32.
8.
Institute. UoWPH. County Health Rankings2015.
9.
New York City Health Provider Partnership Bronx Community Needs 
Assessment: New York Academy of Medicine;2014.
10.
Kim M BD, Matte T. Diabetes in New York City: Public Health Burden and 
Disparities. New York: New York City of Health and Mental Hygiene;2006.
11.
Ngai IM, Van Arsdale A, Govindappagari S, et al. Skin Preparation for Prevention 
of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled 
Trial. Obstetrics and gynecology. Dec 2015;126(6):1251-1257.
12.
Chapman DJ, Perez-Escamilla R. Maternal perception of the onset of lactation is 
a valid, public health indicator of lactogenesis stage II. J Nutr. Dec 
2000;130(12):2972-2980.
13.
Bonuck K, Stuebe A, Barnett J, Labbok MH, Fletcher J, Bernstein PS. Effect of 
primary care intervention on breastfeeding duration and intensity. American 
journal of public health. Feb 2014;104 Suppl 1:S119-127.
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14.
Barnett J, Aguilar S, Brittner M, Bonuck K. Recruiting and retaining low-income, 
multi-ethnic women into randomized controlled trials: successful strategies and 
staffing. Contemporary clinical trials. Sep 2012;33(5):925-932.
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Nommsen-Rivers LA, Chantry CJ, Peerson JM, Cohen RJ, Dewey KG. Delayed 
onset of lactogenesis among first-time mothers is related to maternal obesity and 
factors associated with ineffective breastfeeding. Am J Clin Nutr. Sep 
2010;92(3):574-584.
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Nommsen-Rivers LA, Dolan LM, Huang B. Timing of stage II lactogenesis is 
predicted by antenatal metabolic health in a cohort of primiparas. Breastfeed 
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New York City Department of Health and Mental Hygiene Quality Improvement 
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Accessed 4/10/15.
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IRB APPROVAL DATE: 07/21/2022

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Project Timeline
YEAR 1: 2016-2017
Jul
Au 
g
Se 
p
Oc 
t
No 
v
De 
c
Ja 
n
Fe 
b
Ma 
r
Ap 
r
Ma 
y
Ju 
n
Jul
Au 
g
Se 
p
IRB
submission 
and 
approval
X
X
X
Pilot Data 
Collection 
Forms
X
X
Database 
Developme 
nt
X
X
X
Recruitmen 
t and 
Enrollment
X
X
X
X
X
X
X
X
X
X
X
X
6 week 
follow up
X
X
X
X
X
X
X
X
X
X
X
3 month 
follow-up
X
X
X
X
X
X
X
X
X
6 month 
follow-up
X
X
X
X
X
X
Data Entry
X
X
X
X
X
X
X
X
X
X
X
X
YEAR 2: 2017-2018
Oc 
t
No 
v
De 
c
Ja 
n
Fe 
b
Ma 
r
Ap 
r
Ma 
y
Ju 
n
Jul 
y
Au 
g
Se 
p
Oc 
t
No 
v
De 
c
Recruitmen 
t and 
Enrollment
X
X
X
X
X
X
6 week 
follow-up
X
X
X
X
X
X
X
X
3 month 
follow-up
X
X
X
X
X
X
X
X
X
6 month 
follow-up
X
X
X
X
X
X
X
X
X
X
X
X
Data Entry
X
X
X
X
X
X
X
X
X
X
X
X
Data 
Cleaning 
and 
Analysis
X
X
Manuscript 
Writing
X
X
X
Grant 
Preparation
X
X
X
IRB NUMBER: 2016-6852
IRB APPROVAL DATE: 07/21/2022