Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes

Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes: An Effectiveness-Implementation Hybrid Type 1 Randomized 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.

Inclusion Criteria:

• Age greater than or equal to 18
• Postpartum state (delivered within 6 weeks)
• Ability and willingness to provide informed consent

Exclusion Criteria:

• a history of acute or chronic pancreatitis
• personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
• diagnosis of pre-gestational diabetes (type 1 or 2 diabetes mellitus)
• body mass index <25 kg/m2
• Plan to attempt pregnancy within next 12 months or confirmed pregnancy
• Known allergy to semaglutide from prior exposure
• Previous participation in this trial
• History of suicidal ideation/attempt in the past 12 months
• Current or recent diagnosis in the last 12 months of anorexia nervosa, bulimia nervosa, binge eating disorder, or other eating disorder
• Actively breastfeeding or lactating