NOT_YET_RECRUITING
Preventing T2DM After GDM With Immediate Postpartum Screening and Treatment
The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment with metformin for postpartum patients with pregnancies affected by GDM.
Conditions:
🦠 Gestational Diabetes 🦠 Type 2 Diabetes
🗓️ Study Start (Actual) 1 April 2025
🗓️ Primary Completion (Estimated) 1 April 2028
✅ Study Completion (Estimated) 1 December 2028
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Worcester, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria
    • * receiving prenatal care at UMASS Memorial and plans to deliver at UMASS Memorial
    • * able and willing to provide informed consent
    • * English or Spanish speaking
    • * ability to complete immediate in hospital postpartum glucose testing
    • * have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg/dL or 2-hour glucose value of ≥200 mg/dL

    Exclusion Criteria:

    • * known diagnosis of pre-existing pre-gestational diabetes in pregnancy
    • * inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum
    • * systemic steroid use
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 June 2024
  • First Submitted that Met QC Criteria 12 June 2024
  • First Posted 13 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 June 2024
  • Last Update Posted 13 June 2024
  • Last Verified June 2024