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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT03570632
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women 18-50 years
* 12 0/7 and 19 6/7 weeks of gestation
* Diagnosed with type 1 DM prior to pregnancy.
Exclusion Criteria:
* Known allergy or adverse reaction to metformin
* Multiple gestation
* Abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy
* Medical comorbidities that increase risk for metformin use: renal insufficiency (creatinine \> 1.1 mg/dL), proteinuria (P:C \>0.3 or 24-hour urine protein \> 300 mg), active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes 3x above normal), inflammatory bowel disease (Crohn's and Ulcerative colitis), major hematologic disorder (including alloimmune and isoimmune thrombocytopenia).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03570632
Study Brief:
Protocol Section:
NCT03570632