Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes (NCT05124808) | Clinical Trial Compass
RecruitingNot Applicable
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
United States828 participantsStarted 2022-03-01
Plain-language summary
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant women between the ages of 18-45
* Singleton gestation
* Gestational age between 12 0/7-32 6/7 weeks' gestation with gestational diabetes diagnosed during this time frame using either a 50g 1-hr GCT ≥200 mg/dL or two or more abnormal values on a 100g OGTT using the Carpenter-Coustan Criteria
* Overweight or obese BMI at the first prenatal visit (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)
Exclusion Criteria:
* Inability or unwillingness to provide informed consent
* Inability to communicate with members of the study team, despite the presence of an interpreter
* Planned delivery at a non-study affiliated hospital
* Known renal disease with a baseline creatinine \>1.5 mg/dL
* Significant fetal anomalies diagnosed prior to study enrollment (these will include anomalies such as gastroschisis, spina bifida, complex congenital heart disease, or serious karyotypic anomalies that may lead to early delivery or increased risk of neonatal death)
* Oral or IV/IM steroid use within 7 days of study enrollment
What they're measuring
1
Number of participants with composite neonatal morbidity