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Compares treatment options for Gestational Diabetes Mellitus (GDM)
Official 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)
ClinicalTrials.gov ID: NCT06641141
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older, women only
You may be able to join 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...
- Cephalic presentation.
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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...
- Cephalic presentation.
- Planning to deliver at a participating site.
- Aged 16 years or older.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.