Semaglutide for Postpartum Gestational Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an effectiveness-implementation Hybrid Type 1 study using a randomized clinical trial design to evaluate the effectiveness and potential real-world integration of immediate postpartum semaglutide following a pregnancy complicated by gestational diabetes mellitus (GDM). A total of 226 postpartum individuals with recent GDM will be randomized 1:1 to semaglutide or standard postpartum care for a 6-month active treatment phase. The primary effectiveness outcome, development of metabolic syndrome, will be assessed at 6 months postpartum. Participants will subsequently enter a 6-month maintenance phase, during which semaglutide continuation, discontinuation, or initiation will reflect patient preferences, clinical decision-making, medication access, and insurance coverage.
Are You a Good Fit for This Trial?
This trial is for women who recently had gestational diabetes during pregnancy and are now in the postpartum period. Participants should be generally healthy aside from their recent gestational diabetes, and able to receive injections.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares weekly semaglutide (Wegovy) injections started soon after childbirth versus standard care, to see if it lowers the risk of developing metabolic syndrome within 6 months. Participants are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The intervention/active arm is semaglutide initiated within 1 week of delivery and administered once weekly for 6 months to postpartum individuals following a pregnancy complicated by gestational diabetes mellitus (GDM). Participants randomized to the intervention arm will receive semaglutide in addition to standard postpartum care. Treatment will be initiated using a standardized dose-escalation regimen consistent with the approved prescribing approach to improve tolerability, with dose adjustments or discontinuation based on tolerability and clinical safety.
Participants randomized to the control arm will receive standard postpartum care following a pregnancy complicated by gestational diabetes mellitus (GDM). Standard care will include educational materials addressing postpartum diabetes screening, healthy nutrition, physical activity, weight management, and long-term cardiometabolic risk following GDM. Participants will otherwise receive routine clinical care according to their treating providers and will not receive study-provided semaglutide during the 6-month randomized active phase.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Massachusetts, Worcester
Lead Sponsor
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