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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT03037593
Eligibility Criteria:
Inclusion Criteria:
1. Women who are currently pregnant and receiving prenatal care at the Women's Health Specialists Clinic (University of Minnesota Physicians) from either MD/DO or CNM providers
2. Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks)
3. Subject possesses as least one of the following characteristics:
1. BMI greater than or equal to 30 kg/m2
2. History of gestational diabetes in a prior pregnancy
3. History of infant with birth weight of 4500g or greater
4. Subject is capable of giving informed consent
Exclusion Criteria:
1. Age less than 18 years
2. Multiple gestation pregnancies (twins, triplets or greater multiples)
3. Vitamin D deficiency (defined as less than 20 ng/mL)
4. Preexisting diabetes mellitus defined as either:
1. pre-existing diagnosis prior to current pregnancy
2. failure of three-hour glucose tolerance test in first trimester of pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03037593
Study Brief:
Protocol Section:
NCT03037593