Phase 4
N=150
Breastfeeding Etonogestrel Implant Study
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT03978598 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum — 54; 45; 48; 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Etonogestrel (Drug); Nexplanon (Device)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum |
54; 45; 48; 43 | — |
| SECONDARY Exclusive Breastfeeding |
13; 9 | — |
| SECONDARY Factors Associated With Breastfeeding Discontinuation. |
0.5; 3; 0; 0; 0; 0 | 0.221 |
| SECONDARY Satisfaction With Postpartum Contraception Counseling |
5; 5; 5; 5; 5; 5 | 0.717 |
| SECONDARY Postpartum Mood |
2; 1; 2; 4; 3; 4 | 0.264 |
| SECONDARY Sexual Function |
6; 6; 16; 18.5; 19.9; 21.9 | 0.583 |
| SECONDARY Postpartum Bleeding Days |
14; 14; 14; 12; 25; 11 | 0.60 |
| SECONDARY Satisfaction With the ENG Implant |
1; 1 | 0.0376 sig |
| SECONDARY Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups. |
24; 24 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03978598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.