Intensive glycemic targets for Gestational Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gestational Diabetes+2 MoreIntensive glycemic targets - Other
Eligibility
18 - 45
Female
What conditions do you have?
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Study Summary

This trial is testing whether a more intensive glycemic target is better for overweight and obese individuals with gestational diabetes.

Eligible Conditions
  • Gestational Diabetes
  • Overweight and Obesity
  • High Risk Pregnancies

Treatment Effectiveness

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Within 7 days of delivery

Day 14
Pre-delivery maternal glycemic control
7 days after randomization
Early maternal glycemic control
Birth
Number of participants with large for gestational age birth weight
Number of participants with small for gestational age birth weight
Delivery
Number of participants with preterm birth <37 weeks
Number of participants with primary cesarean delivery
Number of participants with shoulder dystocia
From randomization to delivery
Episodes of maternal hypoglycemia
Maternal hyperglycemia
Number of episodes of symptomatic maternal hypoglycemia
From randomization up to two weeks after delivery
Number of participants with preeclampsia
Hour 24
Number of participants with neonatal hypoglycemia
Day 7
Number of participants with NICU admission
Number of participants with composite neonatal morbidity
Number of participants with neonatal jaundice
Number of participants with respiratory distress syndrome
Hour 72
Number of participants with infant adiposity ≥90th percentile

Trial Safety

Trial Design

2 Treatment Groups

Standard glycemic targets
1 of 2
Intensive glycemic targets
1 of 2

Active Control

Experimental Treatment

828 Total Participants · 2 Treatment Groups

Primary Treatment: Intensive glycemic targets · No Placebo Group · N/A

Intensive glycemic targets
Other
Experimental Group · 1 Intervention: Intensive glycemic targets · Intervention Types: Other
Standard glycemic targets
Other
ActiveComparator Group · 1 Intervention: Standard glycemic targets · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 7 days of delivery

Who is running the clinical trial?

University of OklahomaOTHER
422 Previous Clinical Trials
96,350 Total Patients Enrolled
University of PittsburghOTHER
1,618 Previous Clinical Trials
16,299,099 Total Patients Enrolled
Indiana UniversityLead Sponsor
878 Previous Clinical Trials
759,207 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,827 Previous Clinical Trials
2,249,310 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,437 Previous Clinical Trials
2,228,516 Total Patients Enrolled
Christina Scifres, MDPrincipal InvestigatorIndiana University

Eligibility Criteria

Age 18 - 45 · Female Participants · 4 Total Inclusion Criteria

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