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

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

The EAGER pilot trial is designed to assess the feasibility of a Canadian, multicentre prospective randomized open-label blinded end-point (PROBE) clinical trial addressing whether induction of labour (IOL) at 38 weeks' gestation compared to expectant management (EM) reduces severe perinatal mortality and morbidity among individuals with gestational diabetes mellitus (GDM). Eligible participants will be consented between 32 weeks + 0 days and 38 weeks + 0 days gestation and randomized between 36 weeks + 0 days and 38 weeks + 0 days gestation. Participants will be randomized to one of two arms:

• Intervention Arm: IOL between 38 weeks + 0 days and 38 weeks + 6 days OR
• Control Arm: EM without intervention until spontaneous labour, or earlier if a medical indication arises.

A total of 260 participants (130 per group) will be recruited from Canadian sites, where participants will have 3 study visits:

1. Enrollment and randomization
2. After delivery and up to 72 hours postpartum
3. 6 weeks postpartum At enrollment and randomization, patient-reported baseline and clinical data from medical charts will be collected. Upon admission to hospital for labour and delivery, a blood sample may be collected to assess HbA1C and plasma glucose levels. After delivery and up to 72 hours postpartum, study feasibility will be assessed through patient-reported outcomes and administrative and clinical data. At 6 weeks postpartum, participants will be surveyed for secondary health resource use. Findings from this pilot will inform the design, implementation and feasibility of a future full-scale randomized controlled trial.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus (GDM)
• Intervention / Treatment: Procedure: Induction of Labour

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malia Murphy, PhD; Phone Number: 613-737-8899; Email: malmurphy@ohri.ca
• Study Contact Backup: Name: Serine Ramlawi, MSc; Phone Number: 73840 613-737-8899; Email: sramlawi@ohri.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
      • Contact: Ruth Rennicks White; Phone Number: 78663 613-737-8899; Email: rwhite@toh.ca
      • Principal Investigator: Darine El-Chaâr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Induction of Labour between 38 weeks + 0 days and 38 weeks + 6 days; Induction of Labour between 38+0 weeks and 38+6 weeks.	Procedure: Induction of Labour; 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.; Other Names: IOL; Induction
No Intervention: Expectant Management; Expectant management without intervention until spontaneous labour, or earlier at the discretion of the attending healthcare provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Recruitment Rate	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.	Within 24 months of randomizing the first participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriateness of eligibility criteria	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 (%).	Within 24 months of randomizing the first participant
Participant retention	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 (%).	Within 24 months of randomizing the first participant
Non-compliance	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 (%).	Within 24 months of randomizing the first participant
Participant satisfaction	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.	Within 24 months of randomizing the first participant
Suitability of maternal and neonatal clinical endpoints.	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.	Within 24 months of randomizing the first participant

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Mark C Walker, MD, MSc, MHM, Ottawa Hospital Research Institute; Principal Investigator: Darine El-Chaâr, MD, FRCS(C), MSc, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: gestational diabetes; induction of labour; gestational diabetes mellitus; induction
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational; Therapeutics; Surgical Procedures, Operative; Combined Modality Therapy; Delivery, Obstetric; Obstetric Surgical Procedures; Neoadjuvant Therapy; Labor, Induced
• Other Study ID Numbers: CTO 4937; PJT-191790 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No