Grant: Project Grant

Gestational diabetes mellitus (GDM) is a common pregnancy complication associated with many negative maternal and infant health outcomes. Induction of labour (IOL) at term may improve outcomes for mothers and babies compared to waiting until labour begins spontaneously or until delivery of the infant becomes medically necessary (expectant management). However, current guidelines are based on expert opinion and low-quality data. There remains no consensus on optimal delivery management for GDM. The EAGER Pilot Trial will assess the feasibility of conducting a large Canadian, multi-centre randomized controlled trial to test whether IOL between 38- and 39 weeks' gestation reduces the risk of adverse outcomes compared to expectant management among individuals with GDM. To assess feasibility, we will collect data on the participant recruitment and retention rates and evaluate resource and management needs for collecting important clinical outcome data on the occurrence of severe neonatal complications (e.g., death, the need for breathing support, low Apgar (<4 at 5 min), seizure, sepsis, pneumonia, and other complications), other neonatal outcomes (e.g., birthweight, trauma), maternal outcomes (e.g., unplanned c-section, operative vaginal delivery, 3rd or 4th-degree perineal tears) and health resource use outcomes (e.g., length of stay in hospital, and post-discharge health care use). We will also collect data on participant-reported outcomes (e.g., maternal feelings of control during childbirth, and labour pain), and obtain participant feedback on the study design and procedures. This pilot trial will lay the foundation for a larger-scale and more comprehensive investigation that will inform evidence-based recommendations and resources on pre-labour decision-making and care for individuals with GDM. The knowledge gained from this work will help clinical societies, physicians, and patients improve outcomes for pregnancies with GDM.