Gestational Diabetes Mellitus (GDM)EAGER PilotNCT06641141
The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial (EAGER Pilot Trial)
A study testing Induction of Labour in people with Gestational Diabetes Mellitus (GDM), run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Induction of Labour
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteCanada
- Study dates
- 7 Apr 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Ruth Rennicks White, 613-737-8899 ext. 78663, rwhite@toh.ca
Darine El-Chaar
About this study
Official title: 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.
Read more
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)
- Being tested
- Induction of Labour
- Keywords
- gestational diabetes mellitus, gestational diabetes, induction, induction of labour
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of LabourProcedure or surgery
Also called IOL, Induction
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 months of randomizing the first participant
Secondary outcomes (5)
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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: Within 24 months of randomizing the first participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start7 Apr 2025
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-centre Prospective Randomized Open-label Blinded Endpoint (PROBE) Pilot Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark C Walker, MD, MSc, MHM, Principal investigator, Ottawa Hospital Research InstituteDarine El-Chaâr, MD, FRCS(C), MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641141
- Sponsor's protocol ID
- CTO 4937
- Other IDs
- PJT-191790
- Acronym
- EAGER Pilot
- Status last verified
- Nov 2025
- First submitted
- 11 Oct 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06641141
- Acronym / sponsor ID
- EAGER Pilot / CTO 4937
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- gestational diabetes mellitus, gestational diabetes, induction, induction of labour
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multi-centre Prospective Randomized Open-label Blinded Endpoint (PROBE) Pilot Trial
| Arm | Type | Receives |
|---|---|---|
| Induction of Labour between 38 weeks + 0 days and 38 weeks + 6 days | Experimental | Procedure: Induction of LabourInduction of Labour between 38+0 weeks and 38+6 weeks. |
| Expectant Management | No intervention | –Expectant management without intervention until spontaneous labour, or earlier at the discretion of the attending healthcare provider. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of LabourAlso: IOL, InductionInduction 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. | Procedure or surgery | Induction of Labour between 38 weeks + 0 days and 38 weeks + 6 days |
Primary outcome
Participant Recruitment Rate
Time frame: Within 24 months of randomizing the first participant
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.
5 secondary outcomes
Appropriateness of eligibility criteria
Time frame: Within 24 months of randomizing the first participant
Participant retention
Time frame: Within 24 months of randomizing the first participant
Non-compliance
Time frame: Within 24 months of randomizing the first participant
Participant satisfaction
Time frame: Within 24 months of randomizing the first participant
Suitability of maternal and neonatal clinical endpoints.
Time frame: Within 24 months of randomizing the first participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark C Walker, MD, MSc, MHM principal investigator
Ottawa Hospital Research Institute
Darine El-Chaâr, MD, FRCS(C), MSc principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction of Labour in people with Gestational Diabetes Mellitus (GDM), run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malia Murphy, PhD (613-737-8899, malmurphy@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Rate (time frame: Within 24 months of randomizing the first participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.