Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial

October 31, 2022 updated by: Montefiore Medical Center
The investigators 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The investigators 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 Stage 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.

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10034
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Live pregnancy of at least 24 weeks gestation
  • Intention to use a contraceptive implant postpartum
  • 17 years of age or older
  • English or Spanish speaking
  • Admission to Labor and Delivery with a plan for delivery (women in both latent and active labor will be eligible)

  • The presence of at least one of the following conditions known to be a risk factor for low milk supply:

    • Expected delivery prior to 34 weeks
    • Obesity (pre-pregnancy BMI >35)
    • Polycystic Ovarian Syndrome
    • Diabetes (gestational or pre-gestational)
    • Self-reported difficulty with low milk supply in past

Exclusion Criteria:

  • Not English or Spanish speaking
  • Allergy or Contraindication to contraceptive implant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postplacental
contraceptive implant placed within 30 minutes of placental delivery
Device: Etonogestrel Contraceptive Implant
Women will be randomized to the TIMING of implant placement
Other Names:
  • Nexplanon
Experimental: Immediate Postpartum
Contraceptive Implant placed 1-3 days postpartum
Device: Etonogestrel Contraceptive Implant
Women will be randomized to the TIMING of implant placement
Other Names:
  • Nexplanon
Active Comparator: Delayed
Contraceptive Implant placed 6 or more weeks postpartum
Device: Etonogestrel Contraceptive Implant
Women will be randomized to the TIMING of implant placement
Other Names:
  • Nexplanon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Breastfeeding at 6 Months
Time Frame: 6 months postpartum
Exclusive Breastfeeding at 6 months
6 months postpartum
Time to Lactogenesis Stage II
Time Frame: 1-5 days postpartum
Difference in time to Lactogenesis Stage II
1-5 days postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal Bleeding
Time Frame: 0-6 months postpartum
Number of Participants that reported heavy bleeding at 6 months postpartum
0-6 months postpartum
Satisfaction With Contraceptive Implant
Time Frame: 0-6 months postpartum
Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum
0-6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Erika Levi, MD, MPH, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

April 7, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

August 7, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-6852

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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