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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 30, 2026 → Dec 2026
See other at-risk trials from Ohio State University

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary and study completion pushed from Jun 30, 2026 to Dec 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Notable Trial status: Active, Not Recruiting to Recruitingv7 Show 5 more changesShow less
    • Primary endpoints: 1 to 3
    • Eligibility criteria expanded, about 54 words
    • Study description expanded, about 156 words
    • Site details revised
    • Study title expanded, about 5 words
  3. Notable Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026v6
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Mar 2025 to Jun 30, 2025
    • Study completion date: Jul 2025 to Jun 30, 2025
    • Site details revised
    v5
  5. Minor Primary completion date: Sep 2024 to Mar 2025
    • Study completion date: Dec 2024 to Jul 2025
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Eligibility criteria expanded, about 8 wordsv3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2023 to Jul 24, 2023
    • Site details revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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
Trial Details
NCT Number NCT05909046
Lead Sponsor Ohio State University
Conditions
(from sponsor)
Pre-Gestational Diabetes, Type2diabetes, Pregnancy in Diabetic, Pregnancy, High Risk, Gestational Diabetes, Gestational Diabetes Mellitus in the Puerperium
Related terms Diabetes Mellitus, Type 2, Diabetes, Gestational, Prediabetic State, Pregnancy in Diabetics
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov