Labor and Delivery Implant Insertion: A Randomized Controlled Trial (LADII)

Stanford University

Status and phase: Completed; Phase 3

Conditions: Postpartum Contraception; Family Planning

Treatments: Drug: Etonogestrel-Immediate; Drug: Etonogestrel-Delayed

Study type: Interventional

Funder types: Other

Identifiers

NCT02866643

IRB-38505

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women who are patients of the Stanford University Obstetrics service
• Pregnant women who delivery a healthy infant, regardless of gestational age.
• Intend to breastfeed
• Desire the contraceptive implant as their method of contraception
• Agree to be randomized to delivery room vs. postpartum ward insertion

Exclusion criteria

• Not English or Spanish speaking
• Allergy or Contraindication to contraceptive implant.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Delivery Room Insertion

Experimental group

Description:

Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).

Treatment:

Drug: Etonogestrel-Immediate

Postpartum Insertion

Active Comparator group

Description:

Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).

Treatment:

Drug: Etonogestrel-Delayed