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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01463202
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years old and \> 24 0/7 weeks pregnant at time of enrollment
* Planning to deliver at Magee-Womens Hospital and to breastfeed
* Plans to use DMPA for postpartum contraception for at least 6 months
* Willing and able to provide informed consent in English and to comply with study protocol
Exclusion Criteria:
* Intolerance of irregular vaginal bleeding
* Severe coagulation disorder
* Severe liver disease (LFTs \>2x upper limits of normal at time of randomization)
* Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia
* History of breast cancer, reduction or augmentation surgery
* History of severe clinical depression
* Multiple gestation
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01463202
Study Brief:
Protocol Section:
NCT01463202