Semaglutide for prevention of type 2 diabetes in women with postpartum prediabetes after gestational diabetes: protocol for a Belgian multicentre double-blind randomised placebo-controlled trial

INTRODUCTION: Women with postpartum pre-diabetes following gestational diabetes mellitus (GDM) are at particularly high risk of developing type 2 diabetes mellitus (T2DM). While the implementation of effective lifestyle interventions in the early postpartum period is often difficult and has in general limited efficacy to prevent T2DM after GDM, effective preventive strategies, including medical therapies, are needed in this population. The 'semaglutide for the treatment of pre-diabetes in women with prior gestational diabetes (SERENA) study' aims to evaluate the efficacy, safety and cost-effectiveness of semaglutide in preventing progression to T2DM during the early postpartum period. METHODS AND ANALYSIS: SERENA is a Belgian multicentre, double-blind randomised controlled trial conducted in 13 hospitals. A total of 252 women with a recent history of GDM and postpartum pre-diabetes will be randomised in a 1:1 ratio to receive once-weekly subcutaneous injections of semaglutide 1 mg or placebo in addition to standardised lifestyle intervention. Randomisation is stratified by body mass index at early postpartum assessment (