Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

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.

Eligibility

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

Conditions4

Locations5 sites

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