NCT02866643

Labor and Delivery Implant Insertion: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis. In this trial, the investigators aim to describe the effects of immediate insertion of the contraceptive implant on breastfeeding. The investigators seek to examine the time to lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82 consenting women will be randomized to immediate implant insertion (0-2 hours following delivery) in the delivery room or insertion of the implant following delivery in postpartum room and prior to medical discharge (24-48 hours following delivery). Participants complete a questionnaire that asks questions about breastfeeding continuation, supplementation, duration, and exclusivity. This questionnaire also includes questions about contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care visits.

Conditions

• Postpartum Contraception
• Family Planning

Interventions

Type	Name	Description
DRUG	Etonogestrel-Immediate	The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
DRUG	Etonogestrel-Delayed	The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.

Timeline

• Start date: 2016-10-28
• Primary completion: 2019-09-06
• Completion: 2021-07-31
• First posted: 2016-08-15
• Last updated: 2022-07-25
• Results posted: 2020-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study