Breastfeeding Etonogestrel Implant Study (NCT03978598) | Clinical Trial Compass
CompletedPhase 4
Breastfeeding Etonogestrel Implant Study
United States150 participantsStarted 2019-06-03
Plain-language summary
The investigators are studying the effect of placing the etonogestrel implant (Nexplanon) in the first 24 hours after birth on breastfeeding. Women who wish to have an etonogestrel implant placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the implant placed in the first 24 hours after delivery of the baby and placenta or 4-6 weeks later. The investigators do not believe there will be a difference in breastfeeding 8 weeks after delivery or time to lactogenesis between those who get the implant placed early or later.
Who can participate
Age range
13 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:
* Pregnant women or women who have delivered vaginally and by cesarean section within 22 hours (2-hour window will allow for implant insertion by 24 hours postpartum)
* Aged 13 and older
* English or Spanish speakers
* Deliver an infant at UNM Hospital at \> 37 weeks gestational age
* Intend to breastfeed
* Desire the implant as a method for contraception
* Agree to randomization
* Must have a working phone (study questions to be answered through phone calls or accessed electronically by a link sent through email or text message)
Exclusion Criteria:
* Under age 13
* History of breast cancer (screen by past medical history)
* History of undiagnosed vaginal bleeding (screen by past medical history)
* Head trauma that affected pituitary function (screen by past medical history)
* Prolactin insufficiency (screen by past medical history)
* Previous lactation failure (defined as no lactation within 5 days postpartum)
* Any contraindication to lactation/implant use including diseases transmittable by breast milk (screen by past medical history)
* Liver dysfunction (screen by past medical history)
* Use of drugs that inhibit lactation (screen by medical history)
* Sensitivity to the components of the ENG implant (screen by past medical history)
* Contraindications to use the implant by the (US MEC) (screen by past medical history)
* Active labor
* Delivery at \< 37 weeks gestational age
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
1
Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum
Timeframe: For the primary outcome will be the first eight weeks after delivery.