EAGER Pilot Trial assesses feasibility of induction at 38 weeks versus expectant management for gestational diabetes

Managing gestational diabetes mellitus (GDM) often involves frequent glucose monitoring and insulin adjustments, imposing significant physical, psychological, and economic burdens on pregnant individuals. Current guidelines for GDM management typically recommend induction of labor (IOL) between 38 and 40 weeks, but the optimal timing to balance maternal and fetal outcomes, particularly regarding severe perinatal morbidity and mortality, remains a subject of ongoing debate. This pilot trial addresses the need for robust evidence to guide the timing of delivery in GDM, specifically comparing IOL at 38 weeks to expectant management.

The EAGER pilot trial is a Canadian, multicentre prospective randomized open-label blinded end-point (PROBE) clinical trial. It aims to assess the feasibility of a future full-scale RCT comparing induction of labor (IOL) at 38 weeks' gestation to expectant management (EM) in individuals with gestational diabetes mellitus. A total of 260 participants (130 per group) will be recruited. Participants are randomized between 36 and 38 weeks' gestation to either the intervention arm (IOL between 38 weeks + 0 days and 38 weeks + 6 days) or the control arm (EM until spontaneous labor or medical indication). Data collected includes patient-reported baseline and clinical data, and blood samples for HbA1C and plasma glucose levels may be collected upon admission for labor and delivery.

As a pilot trial, the EAGER study's primary objective is to assess the feasibility and acceptability of the study design and protocol, rather than reporting clinical outcomes. The pilot specifically aims to provide an estimate of enrollment rates and to assess compliance with the study protocol by participants. Feasibility will be evaluated through patient-reported outcomes, administrative data, and clinical data collected after delivery and up to 72 hours postpartum, and again at 6 weeks postpartum for secondary health resource use. The findings from this pilot are intended to directly inform the design, implementation, and feasibility of a future full-scale randomized controlled trial that will ultimately address whether IOL at 38 weeks reduces severe perinatal mortality and morbidity among individuals with gestational diabetes mellitus. No clinical outcome data or feasibility metrics are reported in this abstract, as the trial is currently recruiting.