Phase 3
Completed N=95
Labor and Delivery Implant Insertion: A Randomized Controlled Trial
Postpartum Contraception · Family Planning
Source: ClinicalTrials.gov NCT02866643 ↗
Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Time to Lactogenesis Stage II [Questionnaire] — 65; 67.5 hours
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Lactogenesis Stage II [Questionnaire] |
65; 67.5 | — |
| SECONDARY Number of of Participants Actively Breastfeeding |
13; 16; 10; 8; 9; 6 | — |
| SECONDARY Number of Participants Still With the Contraceptive Implant at Month 12. |
14; 12 | — |
| SECONDARY Number of Participants Satisfied or Very Satisfied With Implant Contraceptive |
16; 10 | — |
| SECONDARY Number of Participants Reporting a Pregnancy Within 12 Months |
1; 1 | — |
| SECONDARY Number of Participants Attending a Postpartum Care Visit by Month 3 |
17; 24 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02866643). 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. Informational only — not medical advice.