Postpartum Family Planning

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ohio State University
• Collaborator: Nationwide Children's Hospital
• Treatments: Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

1. Intend to deliver in the Labor and Delivery Unit at Ohio State University Wexner Medical Center;

2. Are ≥18 years of age;

3. Speak English;

4. Intend to breastfeed, or express milk for their infant, for ≥6 months;

5. Do not want to become pregnant within the first 12 months after delivery;

6. Want to start use of DMPA immediately after delivery before discharge; AND

7. Intend to reside in Ohio for the first 12 months after delivery.

Exclusion Criteria:

8. Undiagnosed vaginal bleeding;

9. Known or suspected malignancy of breast;

10. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease;

11. Liver dysfunction or disease; OR

12. Known hypersensitivity to Depo-Provera.

Women who enroll prenatally will need to rescreen following delivery to confirm their eligibility. Women enrolling after delivery or who are rescreening will need to meet criteria 2-12 above as well as the following eligibility criteria:

1. Are a postpartum patient in the Labor and Delivery Unit at OSUWMC; AND

2. Have delivered a term, singleton infant of ≥2500 grams without any apparent health concerns.