Breastfeeding Etonogestrel Implant Study

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of New Mexico
• Collaborator: Society of Family Planning
• Treatments: Desogestrel; Etonogestrel

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