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Postpartum Family Planning
Phase 4 trial testing Depo-Provera Injectable Product in Delay in Time to Lactogenesis Stage II in 49 participants. Terminated before completion.
| Lead sponsor | Ohio State University |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 21 March 2019 |
| Primary completion | 26 May 2021 |
| Estimated completion | 18 April 2022 |
| Sites | 1 location across United States |
Ohio State University
18 and older, female only, with Delay in Time to Lactogenesis Stage II. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Self-reported time to lactogenesis stage 2 (i.e., milk "let-down")
| Group | Value | 95% CI |
|---|---|---|
| Intervention Arm | 44.8 | 11.3 – 125.6 |
| Placebo Arm | 47.2 | 1.5 – 112.0 |
| Open Arm | 50.4 | 1.0 – 103.4 |
Rates of use of a highly-effective method of contraception (defined here as DMPA, implant, IUD, sterilization, pill, patch, or ring) at 12 months post-delivery among women in the intervention or placebo arm versus those in the open control arm
| Group | Value | 95% CI |
|---|---|---|
| Intervention Arm | 7 | |
| Placebo Arm | 6 | |
| Open Arm | 4 |
Investigators will conduct a randomized controlled trial (RCT) to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and long-term contraceptive use. Investigators will randomize approximately 429 adult women who have delivered a healthy, full-term infant at The Ohio State University Wexner Medical Center (OSUWMC), who intend to breastfeed for ≥6 months, and who want to use DMPA (Depo-Provera; Pfizer Corp.) Note that because of anticipated screening failures, investigators will enroll more than the number randomized (i.e., up to 800 women). Investigators will randomize women to receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection ("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded while the open control arm will be unblinded. Note that postpartum patients at the study site do not receive DMPA before discharge as standard care. At enrollment, women will receive condom counseling and provision and referral for contraception at 12 weeks (intervention and placebo arms) or at 6 weeks postpartum (open control arm). Investigators will collect data on lactogenesis, infant feeding and growth, and contraception use during 12 follow-up months. Investigators conducted a pilot study (N=100) in the target population, which supports the feasibility of the current trial.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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