Randomized comparison of immediate in-hospital 2-hour OGTT versus standard 4–12 week postpartum 2-hour OGTT for people with gestational diabetes
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) - Follow up Study: Patient Perspectives on Postpartum Interventions to Improve Future Maternal CARdiovascular hEalth After Gestational Diabetes (PP CARE)
This will test whether doing a 2-hour OGTT before hospital discharge gets more people who had gestational diabetes screened for diabetes than the usual 4–12 week outpatient test.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05909046 on ClinicalTrials.gov |
What this trial studies
Adults with gestational diabetes delivering at The Ohio State University Wexner Medical Center are randomized during their delivery admission to an immediate inpatient 75-g, 2-hour OGTT before discharge or the usual outpatient 4–12 week 75-g, 2-hour OGTT in a pragmatic, non-blinded design. The primary goal is to increase the frequency of postpartum diabetes screening, with outcomes including OGTT completion rates and detection of impaired glucose tolerance or diabetes. A linked PP CARE component follows English-speaking DIP participants 12–24 months postpartum using surveys and qualitative interviews to identify barriers and facilitators to cardiovascular health counseling and risk-reduction, including social determinants of health and structural factors. The study uses patient-centered mixed methods to inform implementation of postpartum screening strategies at a single large academic medical center.
Who should consider this trial
Good fit: Adults (≥18) delivering at OSU with a pregnancy complicated by gestational diabetes who can give informed consent, speak English or Spanish, and receive prenatal and postpartum care at OSU are ideal candidates.
Not a fit: People with pregestational diabetes, those who cannot tolerate a 2-hour OGTT (for example after gastric bypass), non-English/Spanish speakers not eligible for PP CARE, or those not receiving care at OSU are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, immediate inpatient OGTT could substantially raise screening completion, enable earlier diagnosis of prediabetes or diabetes, and speed access to prevention or treatment.
How similar studies have performed: Prior diagnostic and observational work shows immediate postpartum OGTT has comparable performance to 4–12 week testing for detecting glucose abnormalities, but randomized pragmatic comparisons focused on screening completion and implementation remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Christine Field, MD, MPH — Ohio State University
- Study coordinator: Kartik Venkatesh, MD, PhD
- Email: kartik.venkatesh@osumc.edu
- Phone: 614-293-2222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.