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RecruitingNot ApplicableNCT05909046

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

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)

Sponsor

Ohio State University

Enrollment

104 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

Gestational DiabetesPregnancy, High RiskType2diabetesPregnancy in DiabeticPre-Gestational DiabetesGestational Diabetes Mellitus in the Puerperium

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether doing a blood sugar test immediately after delivery (rather than waiting for the standard 6–12 week postpartum test) can better identify women who had gestational diabetes and may be at risk for developing type 2 diabetes, and whether early support helps them stay healthy afterward. **You may be eligible if...** - You are 18 or older and have just given birth - You were diagnosed with gestational diabetes (diabetes during pregnancy) during this pregnancy - You speak English or Spanish - You receive prenatal and postpartum care at Ohio State University **You may NOT be eligible if...** - You cannot tolerate a 2-hour glucose test (e.g., history of gastric bypass surgery) - You do not speak English or Spanish - Note: A follow-up component of this study (PP CARE) is only available to English-speaking participants Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTImmediate inpatient postpartum OGTT

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

DIAGNOSTIC_TESTStandard of care 4-12 week postpartum OGTT

Standard of care is 4-12 week outpatient postpartum OGTT

Locations(1)

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

Columbus, Ohio, United States

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NCT05909046

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