Status:
ENROLLING_BY_INVITATION
Group Versus Traditional Prenatal Care for Diabetes
Lead Sponsor:
Washington University School of Medicine
Conditions:
Pregnancy
Gestational Diabetes
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 di...
Detailed Description
Long term, the investigator aims to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve, 1.) glycemic control and, 2.) postpartum weight retention...
Eligibility Criteria
Inclusion
- English speaking
- Type 2 diabetes OR gestational diabetes diagnosed by 2-step method(1) OR likely pre-existing Type 2 diabetes with one of the following during pregnancy and \</= 34 weeks:
- 1 hour glucose challenge test \>/= 185mg/dL OR
- A1c \>/= 6.5% OR
- Fasting plasma glucose \> 126mg/dL (2)
- Ability to attend group prenatal visit at specified days and times
- Willingness to be randomized at 22 weeks 0 days-34 weeks 0 days OR initial visit between 24 weeks 0 days-34 weeks 0 days
- Ability to give informed consent
Exclusion
- Prior participation in diabetes group care
- Type 1 Diabetes
- Multiple gestation
- Major fetal anomaly
- Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider.
- Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider.
Key Trial Info
Start Date :
September 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT03301792
Start Date
September 14 2017
End Date
January 1 2026
Last Update
December 19 2025
Active Locations (1)
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1
Washington University in St. Louis
St Louis, Missouri, United States, 63110