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A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE

NCT05909046 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-11-24

No results posted yet for this study

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
  • Gestational Diabetes Mellitus in the Puerperium

Interventions

DIAGNOSTIC_TEST

Immediate inpatient postpartum OGTT

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

DIAGNOSTIC_TEST

Standard of care 4-12 week postpartum OGTT

Standard of care is 4-12 week outpatient postpartum OGTT

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Christine Field, MD, MPH · Ohio State University

  • Kartik K Venkatesh, MD, PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05909046 on ClinicalTrials.gov