Status:
RECRUITING
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE
Lead Sponsor:
Ohio State University
Conditions:
Pre-Gestational Diabetes
Type2diabetes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
DIP : To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum O...
Detailed Description
DIP: Individuals with gestational diabetes (GDM) during pregnancy have up to a 10-fold increased risk of developing of T2DM. Postpartum screening facilitates detection of impaired glucose tolerance an...
Eligibility Criteria
DIP - Inclusion Criteria:
-
Immediately postpartum individuals during their delivery hospital admission
-
≥ 18 years old with the ability to give informed consent.
-
Diagnosed with GDM during pregnancy by:
- Elevated one-hour 50-gram glucose challenge test any time during pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis OR
- Two elevated values on a 3-hour 100-gram glucose tolerance test any time in pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis
-
English or Spanish speaking
-
Receiving prenatal and postpartum care at OSU
DIP- Exclusion Criteria:
- Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)
- Not English or Spanish speaking
PP CARE Inclusion criteria: Enrolled DIP participants who are English speaking will be eligible for PP CARE follow up if they are between 12 and 24 months postpartum.
PP CARE Exclusion criteria: Spanish speaking DIP participants will be excluded because the study team does not include anyone who is Spanish speaking.
Key Trial Info
Start Date :
July 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT05909046
Start Date
July 24 2023
End Date
June 30 2026
Last Update
November 24 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210