CompletedNot Applicable

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

United States155 participantsStarted 2016-11

Plain-language summary

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

Who can participate

Age range

17 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Breastfeeding at 6 Months

Timeframe: 6 months postpartum

Time to Lactogenesis Stage II

Timeframe: 1-5 days postpartum

Trial details

NCT IDNCT02866279

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-07

Results submitted2022-07-12

View on ClinicalTrials.gov More Contraception trials