Recruiting

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

ClinicalTrials.gov IDNCT05909046

PhaseNA

Enrollment104

SponsorOhio State University

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Pre-Gestational Diabetes, Type2diabetes, Pregnancy in Diabetic, Pregnancy, High Risk, Gestational Diabetes, Gestational Diabetes Mellitus in the Puerperium

About this study

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

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

Primary outcomes

Rate of postpartum diabetes mellitus screening (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 (Within the first 12 months after delivery)
Patient perspectives, preferences and barriers to engagement with respective to postpartum interventions to improve CVH. (Between 12 and 24 months postpartum)

Eligibility information

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 locations

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus, Ohio 43210 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.