Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorIndiana University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intensive glycemic targets
Other interventionFasting blood glucose \<90 mg/dL, 1 hour post-prandial blood glucose \<120 mg/dL
Standard glycemic targets
Other interventionFasting blood glucose \<95 mg/dL, 1 hour post-prandial blood glucose \<140 mg/dL
Treatment groups
828 Participants
are divided into 2 treatment groupsGroup A: Intensive glycemic targetsExperimental treatment 1 intervention
Group B: Standard glycemic targetsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with composite neonatal morbidity
Composite of large for gestational age birth weight, neonatal hypoglycemia, neonatal jaundice, and neonatal respiratory distress syndrome
Time frame
Within 7 days of deliverySecondary outcomes
1
Number of participants with large for gestational age birth weight
≥90th percentile birth weight for gestational age, based on US birth weight normograms
Time frame
Birth2
Number of participants with neonatal hypoglycemia
Blood glucose \<40 mg/dL in the 1st 24 hours of life
Time frame
Within 24 hours of delivery3
Number of participants with neonatal jaundice
Documentation of need for phototherapy
Time frame
Within 7 days of delivery4
Number of participants with respiratory distress syndrome
Signs of respiratory distress (tachypnea, grunting, nasal flaring, cyanosis) with an oxygen requirement within the first 24 hours of life and the presence of radiologic chest findings of hypoaeration and reticulogranular infiltrates or those needing immediate intubation for respiratory distress syndrome
Time frame
Within 7 days of deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
University of Pittsburgh
Collaborator
University of Alabama at Birmingham
Collaborator
University of Oklahoma
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Women and Infants Hospital of Rhode Island
Collaborator
Source ClinicalTrials.gov