Status:
TERMINATED
Postpartum Family Planning
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Nationwide Children's Hospital
Emory University
Conditions:
Delay in Time to Lactogenesis Stage II
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 r...
Detailed Description
Postpartum women often are inadequately protected against rapid repeat pregnancy. Ensuring adequate inter- birth intervals could prevent an estimated 9% of deaths worldwide among children less than 5 ...
Eligibility Criteria
Inclusion
- Intend to deliver in the Labor and Delivery Unit at Ohio State University Wexner Medical Center, Grady Memorial Hospital or Emory University Midtown;
- Are ≥18 years of age;
- Speak English;
- Intend to breastfeed, or express milk for their infant, for ≥6 months;
- Do not want to become pregnant within the first 12 months after delivery;
- Want to start use of DMPA immediately after delivery before discharge or no hormonal contraception immediately postpartum; AND
- Intend to reside in Ohio or Georgia for the first 12 months after delivery.
Exclusion
- Undiagnosed vaginal bleeding;
- Known or suspected malignancy of breast;
- Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease;
- Liver dysfunction or disease; OR
- 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:
- Are a postpartum patient in the Labor and Delivery Unit at OSUWMC, Grady Memorial Hospital or Emory University Midtown Hospital; AND
- Have delivered a term, singleton infant of ≥2500 grams without any apparent health concerns.
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03844633
Start Date
March 21 2019
End Date
April 18 2022
Last Update
May 7 2024
Active Locations (1)
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1
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210