Pilot study explores early induction for gestational diabetes
NCT ID NCT06641141
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study is testing whether it's practical to run a larger trial that compares inducing labor at 38 weeks versus waiting for natural labor in people with gestational diabetes. About 260 participants will be randomly assigned to either early induction or expectant management. The main goal is to see if enough people can be recruited and if the study procedures work well, not to determine if one approach is safer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Induction of labour (a procedure to start labor using medications or techniques)
- What this could lead to
- If successful, this pilot could pave the way for a larger trial that may show whether inducing labor at 38 weeks improves outcomes for mothers with gestational diabetes.
- What could go wrong
- This is a small pilot study focused on feasibility, not on proving safety or effectiveness. Results may not apply to all patients, and the larger trial may still fail to show benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 be based on the embryo age at transfer. * Cephalic presentation. * Planning to deliver at a participating site. * Aged 16 years or older. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Ottawa Hospital
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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