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Completed

NCT Number: NCT02866643

Labor and Delivery Implant Insertion: A Randomized Controlled Trial

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.

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Key information

Conditions

Postpartum Contraception Behavior Breast Feeding Family Planning Feeding Behavior

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Obstetrics--Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etonogestrel-Immediate

Drug

The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).

Other names: Nexplanon, Contraceptive Implant

Etonogestrel-Delayed

Drug

The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.

Other names: Nexplanon, Contraceptive Implant

Primary outcomes

  1. Time to Lactogenesis Stage II [Questionnaire]

    Time frame: Participants will be monitored daily by the research staff, in the first seven days postpartum, or until lactogenesis reported, beginning at 24-hours following delivery, to determine time to lactogenesis stage II.

    Lactogenesis Stage II: The initiation of copious milk secretion as documented by maternal perception.

    To obtain measurement of time to lactogenesis, we will document time at which participants perceive initiation of copious milk secretion using a set of specific validated questions and subtract this by the documented time of delivery.

Secondary outcomes

  1. Number of of Participants Actively Breastfeeding

    Time frame: 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery

    Exclusive breastfeeding means feedling with breast milk only. Any breast feeding means feeding with breast milk, with water and/or formula.

  2. Number of Participants Still With the Contraceptive Implant at Month 12.

    Time frame: month 12

  3. Number of Participants Satisfied or Very Satisfied With Implant Contraceptive

    Time frame: month 12

    Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied.

  4. Number of Participants Reporting a Pregnancy Within 12 Months

    Time frame: 12 months

  5. Number of Participants Attending a Postpartum Care Visit by Month 3

    Time frame: month 3

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: LADII

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Aug 15, 2016
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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