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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT05909046
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Immediate inpatient postpartum OGTT — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    Standard of care is 4-12 week outpatient postpartum OGTT

Study Details

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

Key Dates

Start date
Jul 24, 2023
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

Rate of postpartum diabetes mellitus screening [ Time Frame: From delivery to up to 12 weeks postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210
Kartik Venkatesh, MD, PhD
[email protected]
614-293-2222

Find similar trials in Columbus, OH

By research site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine· Columbus, OH

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