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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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: 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Contact Information
Primary
Malia Murphy, PhD
malmurphy@ohri.ca
613-737-8899
Backup
Serine Ramlawi, MSc
sramlawi@ohri.ca
613-737-8899
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2028-03
Participants
Target number of participants: 260
Treatments
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.
No_intervention: Expectant Management
Expectant management without intervention until spontaneous labour, or earlier at the discretion of the attending healthcare provider.
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov