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Postpartum Family Planning

NCT03844633 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-05-07

Study results available
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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.

Conditions

  • Delay in Time to Lactogenesis Stage II

Interventions

DRUG

Depo-Provera Injectable Product

Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth

DRUG

Placebos

Placebos -- Shot administered within 48 hours of childbirth

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Maria Gallo, PhD · The Ohio State University, College of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2021-05-26
Completion
2022-04-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03844633 on ClinicalTrials.gov