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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT03326232
Eligibility Criteria:
Inclusion Criteria:
* maternal age 18 to 45
* singleton gestation
* gestational age less than 32 weeks gestation at study inclusion
* BMI less than 45
* 50g glucose challenge greater than 135 mg/dL
* 100 g 3 hr oral glucose tolerance test greater than 2 abnormal values using the Carpenter Coustan cut offs (fasting greater than 95 mg/dL, 1 hr greater than 180 mg/dL, 2 hr greater than 155 mg/dL, 3 hr greater than 140 mg/dL)
* attended the maternal-fetal medicine diabetes education class
Exclusion Criteria:
* maternal age less than18 or greater than 45
* multifetal gestation
* gestational age greater than 32 weeks study inclusion
* BMI greater than 45
* pregestational diabetes
* gestational diabetes diagnosed before 24 weeks
* did not attend the diabetes education class
* known fetal anomaly
* known fetal aneuploidy
* required ongoing treatment with medications that can exacerbate hyperglycemia (steroids, hydroxyprogesterone caproate injections (Makena), highly active antiretroviral therapy HIV medications)
* learning disability
* concern for non compliance with medical care
* imminent preterm delivery due to maternal disease or fetal conditions
* is not willing to wear CGM
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03326232
Study Brief:
Protocol Section:
NCT03326232