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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT04051359
Eligibility Criteria:
Inclusion Criteria:
1. Ages 18-45 years
2. GDM diagnosed between 12 and 34 weeks gestation according to Carpenter and Coustan criteria (13)
3. BMI 20-35 kg/m2
4. Singleton pregnancy
5. Willing to perform self-monitoring of blood glucose at least 4 times a day
6. Self-monitoring of blood glucose
7. 12 to 34 weeks of gestation at the time of randomization
8. Signed informed consent
Exclusion Criteria:
1. Pre-existing diabetes in pregnancy, including first trimester fasting glucose ≥105 mg/dL
2. Use of other oral hypoglycemic agents during this pregnancy
3. Multiple pregnancy
4. Known hepatic insufficiency (bilirubin \>50 µmol/L and/or protrombin time \<50 %)
5. Insufficient understanding
6. Participant in another investigational drug study at inclusion visits
7. Fetal malformation diagnosed by previous fetal ultrasound
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04051359
Study Brief:
Protocol Section:
NCT04051359