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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT00619632
Eligibility Criteria:
Inclusion Criteria:
* Enrolled/plan to remain in care at the site throughout their pregnancy
* 1st or 2nd trimester (randomization will include trimester as a blocking factor)
* Aged 18 or older
* Can provide a reliable phone number and at least 2 alternative contacts
* Are carrying a singleton pregnancy
* Can communicate in English or Spanish
Exclusion Criteria:
* High risk of prematurity/NICU (e.g., ESRD, multiple prior preterms, congenital anomalies)
* Medical/obstetrical complications for which BF is or may be perceived to be contra-indicated (e.g., HIV+, HTLV-1, breast reduction surgery, Hepatitis B and C, pre-gestational diabetes )
* On chronic medications incompatible with BF (e.g., hypoglycemics, lithium, ciprofloxacin)
* Enrolled in site's Group Pre-natal Care (app. 60 women/year)
* Previously enrolled in MILK study
* Craniofacial or neurological conditions that prevent an infant from BF (post-partum exclusion)
* Reported use of street drugs (responds to reviewer comment of how to control for this)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00619632
Study Brief:
Protocol Section:
NCT00619632