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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT02308735
Eligibility Criteria:
Inclusion Criteria: (understood to include only abstemious women)
1. . Pregnant women expected to deliver between 37 and 41 weeks gestation (controls), and their babies
2. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A1 diabetes mellitus, and their babies
3. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A2 diabetes mellitus, and their babies
4. . Pregnant women expected to deliver between 37 and 41 weeks gestation who were diagnosed with diabetes mellitus prior to their pregnancy, and their babies.
Exclusion Criteria:
1. . Mothers who self-reported any alcohol or any illicit drug use during their pregnancy (and their babies)
2. . Mothers who had a positive drug screen at any point during their pregnancy (and their babies)
3. . Babies whose mothers suffered a placental abruption during their pregnancy.
4. . Babies whose mothers had inadequate prenatal care (defined as \<3 prenatal clinic visits prior to admission for delivery)
5. . Non-English-speaking mothers
6. . Babies who pass meconium in utero.
7. . Babies born with multiple congenital anomalies or abdominal wall defects.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
45 Years
Study:
NCT02308735
Study Brief:
Protocol Section:
NCT02308735