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

Last updated: April 14, 2025
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Induction of Labour

Clinical Study ID

NCT06641141
CTO 4937
PJT-191790
  • Ages > 16
  • Female

Study 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 recruited 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 will 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of GDM after 24 weeks of gestation, based on documented 1-step or 2-stepscreening 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 onan ultrasound in the first or second trimester [≤ 23 weeks + 0 days]. Forpregnancies conceived by in vitro fertilization, dating will be based on the embryoage at transfer.

  • Cephalic presentation.

  • Planning to deliver at a participating site.

  • Aged 16 years or older.

Exclusion

Exclusion Criteria:

  • Pre-pregnancy diabetes mellitus.

  • Any obstetrical/maternal indication for immediate delivery including placentaabruption, abnormal fetal well-being either by non-stress test or biophysicalprofile, history of venous thromboembolism (VTE) on low molecular weight heparin,pre-existing hypertension, gestational hypertension, preeclampsia, eclampsia, orHemolysis, elevated liver enzymes and low platelets (HELLP) syndrome at the time ofrandomization.

  • Contraindication to labour and/or vaginal delivery.

  • Signs of labour (regular uterine contractions accompanied by cervical dilationand/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 Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: Induction of Labour
Phase:
Study Start date:
April 07, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

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