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NCT03844633 · ClinicalTrials.gov registry record · Phase 4
Postpartum Family Planning
A Phase 4 study, sponsored by Ohio State University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
NCT03844633 is a Phase 4 study that was terminated before completion, run by Ohio State University. The registered enrollment target is 49 participants.
The verdict
NCT03844633, a Phase 4 study, was terminated before completion, sponsored by Ohio State University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebos
- DRUG Depo-Provera Injectable Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2019-03-21 |
| Est. Completion | 2022-04-18 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03844633
The ClinicalTrials.gov registry entry for NCT03844633 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03844633 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03844633 about?
NCT03844633 is a clinical study titled "Postpartum Family Planning". 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 St...
What is the current status of trial NCT03844633?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2019-03-21. Estimated completion is 2022-04-18.
What interventions are being tested in trial NCT03844633?
The interventions under investigation include: Placebos (DRUG), Depo-Provera Injectable Product (DRUG).
Who is sponsoring clinical trial NCT03844633?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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