Preventing T2DM After GDM With Immediate Postpartum Screening

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT06457139
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Glucose tolerance test (2 hour) — DIAGNOSTIC_TEST
    Early testing with the 2 hour glucose tolerance test will occur during their inpatient postpartum hospitalization.
  • Active Comparator — OTHER
    Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.

Study Details

The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.

Key Dates

Start date
Jun 1, 2025
Status verified
Jul 2025
Primary completion
Jun 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Early Postpartum GDM Screening
    Subjects who are randomly assigned to this condition will be screened for GDM with the recommended 2-hour glucose tolerance test during their postpartum hospitalization.
  • Active Comparator: Standard of Care Postpartum Screening
    Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of screening with a 2 hour glucose tolerance test at 6-12 weeks postpartum.

Primary Outcome Measure

Detection of Type 2 Diabetes Mellitus [ Time Frame: At time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Massachusetts Memorial Medical CenterWorcesterMassachusetts01605
Gianna L Wilkie, MD
[email protected]
508-334-4067

Find similar trials in Worcester, MA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Massachusetts Memorial Medical Center· Worcester, MA

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