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Early labour induction versus waiting in pregnancy with gestational diabetes

Tests whether a larger trial of inducing labour at 38 weeks is workable.

Key facts

Who runs it
Ottawa Hospital Research Institute
Where
Canada1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial (EAGER Pilot Trial)
Status
Recruiting
People taking part
260 people, planned
Started
7 Apr 2025
Expected to end
Mar 2028
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Induction of Labour
Record updated
18 November 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for pregnant people with diabetes that started in pregnancy (gestational diabetes). It compares starting labour at 38 weeks with waiting for labour to start naturally.

Age
16 years or older
Sex
Female
Disease stage
Gestational diabetes diagnosed after 24 weeks of pregnancy by standard tests. One live baby, head-down, at 36 weeks + 0 days to 38 weeks + 0 days of pregnancy. Must plan to give birth at a participating site.
Earlier treatment
People who had a Cesarean delivery before cannot join.

Main reasons for not taking part

  • Diabetes before the pregnancy
  • High blood pressure, preeclampsia or other reasons for immediate delivery
  • Signs of labour, broken waters or heavy vaginal bleeding at randomization
  • Placenta problems (previa, accreta, vasa previa) or a stitch in the cervix (cerclage) in this pregnancy
  • Known major problem in the baby, low fluid around the baby, or poor baby growth

This trial only enrols pregnant participants. The registry sentence this rests on: * 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.

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior Cesarean delivery
  • Pre-pregnancy diabetes mellitus
  • Significant vaginal bleeding or ruptured membranes at the time of randomization
  • Known major fetal anomaly (e.g., gastroschisis, congenital heart defects)
  • 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
  • Placenta previa, placenta accreta, or vasa previa
  • Cerclage in current pregnancy
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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.

The 2 groups in the trial

  • Induction of Labour between 38 weeks + 0 days and 38 weeks + 6 daysTreatment being tested

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

    Treatment: Induction of Labour

  • Expectant ManagementNo study treatment, for comparison

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial
Plain-language title
Early labour induction versus waiting in pregnancy with gestational diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
18 November 2025