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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The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States, 43210