No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
828 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
This trial is looking for overweight and obese pregnant women who have been diagnosed with gestational diabetes. Participants will compare different approaches to blood sugar control during pregnancy.
Are You a Good Fit for This Trial?
You may be able to join if
I am a pregnant woman aged 18-45
I have a single baby
I am between 12 and 32 weeks pregnant and have gestational diabetes
I have a BMI of 25 or higher, or 23 or higher if I am Asian American
You may not be able to join if
I cannot give informed consent
I cannot communicate with the study team, even with an interpreter
I plan to deliver at a hospital not part of this study
I have known kidney disease with high creatinine levels
I have serious fetal issues diagnosed before joining the study
I have used steroids in the week before joining the study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
Trial Locations
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Status
Eligibility Criteria
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 Car…
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
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