Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03844633
Eligibility Criteria:
Inclusion Criteria:
1. Intend to deliver in the Labor and Delivery Unit at Ohio State University Wexner Medical Center, Grady Memorial Hospital or Emory University Midtown;
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 or no hormonal contraception immediately postpartum; AND
7. Intend to reside in Ohio or Georgia 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, Grady Memorial Hospital or Emory University Midtown Hospital; AND
2. Have delivered a term, singleton infant of ≥2500 grams without any apparent health concerns.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03844633
Study Brief:
Protocol Section:
NCT03844633