The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial (EAGER Pilot Trial)

• Induction of Labour (Procedure), also known as IOL, Induction: Induction of Labour (IOL) will occur between 38+0 weeks and 38+6 weeks. All participating sites will follow an evidence-based approach for IOL, which may include any of the following: use of prostaglandins, oxytocin, amniotomy, or intracervical balloon catheters with and without extra-amniotic saline infusion for the intervention arm. Participants who are induced in either the intervention or control arms will be managed by their delivery care provider to ensure sufficient time to labour and determine when to proceed to Cesarean delivery. What constitutes a "failed" IOL will be dictated by local clinical practice guidelines and will be informed by the time since IOL (24-48 hours) and/or physician diagnosis of labour dystocia.

Primary outcomes

• Participant Recruitment Rate [Within 24 months of randomizing the first participant]: The pilot trial will be considered feasible if least 75% of the target sample can be recruited after 24 months of recruitment. The number of screened, approached, consented and randomized individuals will be recorded to assess feasibility. Recruitment rate will be measured by the proportion of eligible participants enrolled (consented and randomized) into the study.

Secondary outcomes

• Appropriateness of eligibility criteria [Within 24 months of randomizing the first participant]: The appropriateness of the eligibility criteria will be assessed. This will be measured as the proportion of screened participants who are excluded overall and per exclusion criterion. It will be reported as numbers (n) and percentages (%).
• Participant retention [Within 24 months of randomizing the first participant]: Participant retention will be assessed. This will be measured as the rate of loss to follow-up or withdrawal of consent from randomized participants. It will be reported as numbers (n) and percentages (%).
• Non-compliance [Within 24 months of randomizing the first participant]: Participant and healthcare provider non-compliance will be assessed. This will be measured as the proportion of participants who receive off-protocol delivery management, including late IOL. It will be reported as numbers (n) and percentages (%).
• Participant satisfaction [Within 24 months of randomizing the first participant]: Participant satisfaction with participating in this study will be assessed. This will be assessed via established surveys: The Labour Agentry Scale, the Study Participant Feedback Questionnaire and the Decisional Regret Scale.
• Suitability of maternal and neonatal clinical endpoints. [Within 24 months of randomizing the first participant]: Suitability of maternal and neonatal clinical endpoints for an eventual full-scale trial will be assessed. This will be assessed based on expert consultation (clinical experts and individuals with lived experience) and will account for the rate of occurrence of severe maternal and neonatal outcomes, and quality and completeness of collected data.

Sex: Female, ages: 16 Years to any

Inclusion Criteria:

* Diagnosis of GDM after 24 weeks of gestation, based on documented 1-step or 2-step screening and diagnostic tests for GDM.
* Singleton fetus at randomization.
* Confirmed live fetus within 24 hours prior to randomization.
* Gestational age between 36 weeks + 0 days and 38 weeks + 0 days inclusive based on an ultrasound in the first or second trimester \[≤ 23 weeks + 0 days\]. For pregnancies conceived by in vitro fertilization, dating will be based on the embryo age at transfer.
* Cephalic presentation.
* Planning to deliver at a participating site.
* Aged 16 years or older.

Exclusion Criteria:

* Pre-pregnancy diabetes mellitus.
* Any obstetrical/maternal indication for immediate delivery including placenta abruption, abnormal fetal well-being either by non-stress test or biophysical profile, history of venous thromboembolism (VTE) on low molecular weight heparin, pre-existing hypertension, gestational hypertension, preeclampsia, eclampsia, or Hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome at the time of randomization.
* Contraindication to labour and/or vaginal delivery.
* Signs of labour (regular uterine contractions accompanied by cervical dilation and/or effacement) at the time of randomization.
* Significant vaginal bleeding or ruptured membranes at the time of randomization.
* Prior Cesarean delivery.
* Placenta previa, placenta accreta, or vasa previa.
* Cerclage in current pregnancy.
* Known major fetal anomaly (e.g., gastroschisis, congenital heart defects).
* Known oligohydramnios (AFI < 5 or MVP < 2 or no 2 by 2 pocket).
* Known fetal growth restriction (EFW < 3rd percentile).
* Refusal of blood products.
* Use of unregulated substances.

• Mark C Walker, MD, MSc, MHM, Principal investigator, Ottawa Hospital Research Institute
• Darine El-Chaâr, MD, FRCS(C), MSc, Principal investigator, Ottawa Hospital Research Institute