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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT02109094
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women ages 18-45, pre-pregnancy BMI 18-30 with normal glycemic control scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
* Pregnant women ages 18-45, pre-pregnancy BMI \>30 with normal glycemic control scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
* Pregnant women ages 18-45 with diabetes (gestational or pre-existing type 2 DM) scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
* Non-pregnant, non-diabetic women age 18-45 scheduled for lumbar puncture at the Yale-New Haven Hospital Lumbar puncture clinic
* Able to read and understand English at 6th grade level or higher
Exclusion Criteria:
* Medical disorders other than diabetes. Including psychiatric disorders, alcohol abuse, HIV, hepatitis, renal, hepatic disease, heart disease, active systemic infection, malignancy
* Pregnancy related medical problems including preeclampsia
* Major congenital fetal anomalies
* Smoking and illicit drugs (marijuana, cocaine, benzodiazepines, barbituates)
* Use of weight loss supplements or dieting 6 months prior to study.
* Corticosteroid use within 6 months of study.
* Uncontrolled thyroid disease
* Medications other than multivitamin, folic acid, or diabetic medications.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02109094
Study Brief:
Protocol Section:
NCT02109094