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:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT02221895
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or above at time of delivery
* Delivery of live born infant at estimated gestational age (EGA) ≥37wk
* Postpartum primiparous patients within the first 48 hours after delivery
* Patient intent to breastfeed
* Breastfeeding initiated within the first 48 hours of delivery and/or prior to hospital discharge (whichever occurs first)
* Infant is continuously rooming in with mother from the time of delivery
* English-speaking
* Able to read and complete surveys
* No anticipated discharge from military system, Tricare benefits, or move planned in the upcoming 6 months
* Willing to render informed consent
Exclusion Criteria:
* Patients delivered by the Family Medicine Department (relatively small number in our population who are not followed postpartum by the Department of Obstetrics and Gynecology)
* Any condition deemed by patient provider to be an absolute contraindication to breastfeeding
* Maternal HIV/AIDS
* Planned use of radioactive or chemotherapeutic medications or medication for other medical problems which is contraindicated for delivery
* Known fetal factor that would impair breastfeeding
* Fetal mid-facial defects
* Known fetal chromosomal abnormality
* Known fetal conditioning resulting in fetal hypotonia
* Labor and Delivery complications
* Maternal separation from infant during the first 48 hours postpartum (such as maternal ICU admission, infant NICU admission)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02221895
Study Brief:
Protocol Section:
NCT02221895