Comparing glycemic targets in overweight and obese women with gestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized clinical trial involves 828 overweight and obese pregnant women diagnosed with gestational diabetes. The study aims to compare the effects of intensive glycemic targets against standard glycemic targets on perinatal outcomes. Participants will be monitored throughout their pregnancy to assess the impact of these glycemic control strategies on complications associated with gestational diabetes. The trial is conducted across four medical centers in the U.S. with high obesity rates, ensuring a diverse participant pool.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting
• University of Oklahoma
  Norman, Oklahoma, United States Recruiting
• University of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting
• Women and Infants Hospital of Rhode Island
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Christina Scifres, MD — Indiana University
• Study coordinator: Rasika Sadolikar, MBBS, MPH
• Email: rsadolik@iu.edu
• Phone: (317)278-8040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.