Recruiting

Postpartum OGTT

Sponsor:

Ohio State University

Code:

NCT05909046

Conditions

Pre-Gestational Diabetes

Type2diabetes

Pregnancy in Diabetic

Pregnancy, High Risk

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immediate inpatient postpartum OGTT

Standard of care 4-12 week postpartum OGTT

Study Details

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 OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM.

Follow up PP CARE: To engage with individuals with a history of GDM through a patient-centered mixed-methods survey and qualitative assessment to evaluate the barriers to and facilitators of Cardiovascular health (CVH) counseling and risk-reduction postpartum at the patient and healthcare system levels inclusive of Social determinants of health (SDOH) and structural factors, as well as patient preferences and perspectives on CVH and wellness interventions

Conditions

Pre-Gestational Diabetes

Type2diabetes

Pregnancy in Diabetic

Pregnancy, High Risk

Gestational Diabetes

Study ID

NCT05909046

Start date

Jul 24, 2023

Status verified date

Nov, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Immediate inpatient postpartum OGTT

The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge

other: Standard of care

Standard of care is 4-12 week outpatient postpartum OGTT

Interventions

Immediate inpatient postpartum OGTT

The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge

Standard of care 4-12 week postpartum OGTT

Standard of care is 4-12 week outpatient postpartum OGTT

Primary outcome measure

  • Rate of postpartum diabetes mellitus screening [ Time Frame: From delivery to up to 12 weeks postpartum ]
  • Patient reported outcome of postpartum Cardiovascular health (CVH) counseling received within the first 12 months after delivery [ Time Frame: Within the first 12 months after delivery ]
  • Patient perspectives, preferences and barriers to engagement with respective to postpartum interventions to improve CVH. [ Time Frame: Between 12 and 24 months postpartum ]

Central Contacts and Locations

Central contacts

Kartik Venkatesh, MD, PhD

614-293-2222kartik.venkatesh@osumc.edu

Locations

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

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kartik Venkatesh, MD, PhD

614-293-2222Kartik.Venkatesh@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • 2-hour oral glucose tolerance test (OGTT)
  • Pregnancy
  • diabetes mellitus screening
  • postpartum
  • cardiometabolic health
  • cardiovascular health
  • type 2 diabetes
  • prediabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-11-24.