Clinical Trial

Postpartum Family Planning

Study Description

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 State University Wexner Medical Center (OSUWMC), who intend to breastfeed for a?Y6 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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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

Additional Information

Official Study Title

Initiation of Injectable Contraception Immediately Postpartum Among Breastfeeding Women

Clinical Trial ID

NCT03844633

ParticipAid ID

b68VLe