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

NCT06641141 | Recruiting DMC

• 2 other identifiers: CTO 4937PJT-191790
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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:
• Enrollment and randomization
• After delivery and up to 72 hours postpartum
• 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.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

gestational diabetes mellitus; gestational diabetes; induction; induction of labour

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Appropriateness of eligibility criteria

  Within 24 months of randomizing the first participant

• Participant retention

  Within 24 months of randomizing the first participant

• Non-compliance

  Within 24 months of randomizing the first participant

• Participant satisfaction

  Within 24 months of randomizing the first participant

• Suitability of maternal and neonatal clinical endpoints.

  Within 24 months of randomizing the first participant

Study Arms (2)

Induction of Labour between 38 weeks + 0 days and 38 weeks + 6 days

EXPERIMENTAL

Induction of Labour between 38+0 weeks and 38+6 weeks.

Procedure: Induction of Labour

Expectant Management

NO INTERVENTION

Expectant management without intervention until spontaneous labour, or earlier at the discretion of the attending healthcare provider.

Interventions

Induction of Labour PROCEDURE

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.

Also known as: IOL, Induction

Induction of Labour between 38 weeks + 0 days and 38 weeks + 6 days

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Labor, Induced; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics

Study Officials

• Mark C Walker, MD, MSc, MHM

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Darine El-Chaâr, MD, FRCS(C), MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malia Murphy, PhD

CONTACT

613-737-8899; malmurphy@ohri.ca

Serine Ramlawi, MSc

CONTACT

613-737-8899; sramlawi@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multi-centre Prospective Randomized Open-label Blinded Endpoint (PROBE) Pilot Trial

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CA (1)