Timing delivery for gestational diabetes: What's the safest week?
NCT ID NCT05515744
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aimed to find the best time (between 37 and 39 weeks of pregnancy) to deliver babies of women with poorly controlled gestational diabetes. Researchers planned to enroll up to 3,450 pregnant women but stopped early with 304 participants. The goal was to see which delivery timing led to the fewest health problems for newborns.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors decide the safest time to deliver babies when the mother has gestational diabetes, reducing newborn complications.
- What could go wrong
- The trial was terminated early and enrolled only 304 out of a planned 3,450 participants, so results may be limited and not conclusive.
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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304 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Dec 2024
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
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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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: Aim 3 (GDM randomized trial, TIME) inclusion criteria: Women inclusion criteria: 1. Age ≥ 18 Years 2. Verified diagnosis of Gestational Diabetes Mellitus (GDM) with abnormal glucose levels\*\*\* or meeting other criteria for poor control, specifically any one of the following: Estimated fetal weight ≥90th percentile (LGA), Polyhydramnios, and or Demonstrate noncompliance or nonadherence as defined clinically, including missing visits, not keeping accurate log, etc. \*\*\*One or more elevated fasting blood glucoses OR three or more elevated post-prandial blood glucoses after receiving education about appropriate diet and lifestyle modification (e.g. physical activity) 3. Accurate gestational age as verified by ultrasound 4. Singleton gestation 5. English or Spanish speaker 6. Plans to deliver at the study site hospital 7. Ability to provide informed consent to be randomized to initiation of delivery EXCLUSION CRITERIA: Aim 3 (GDM randomized trial, TIME) exclusion criteria: 1. Pre-gestational diabetes\* \*will be defined as diabetes diagnosis before pregnancy OR before 13 weeks of gestation with a documented fasting plasma glucose ≥ 126 mg/dL, random plasma glucose ≥ 200 mg/dL, 2 hour post glucose ≥ 200 mg/dL during an oral glucose tolerance test (75 g glucose load), or hemoglobin A1c ≥ 6.5%.110. 2. Previous stillbirth defined as fetal demise ≥ 20 weeks of gestation 3. Self-reported history of alcohol dependency disorder and/or other drug/substance dependency in the past year 4. Teratogen exposure (e.g. cyclophosphamide, valproic acid, warfarin) 5. Known infectious diseases associated with neonatal morbidity (e.g. malaria, cytomegalovirus, rubella, toxoplasmosis, syphilis or Zika virus) 6. Genetic disorders, aneuploidy and known major fetal anomalies 7. Fetal demise 8. Pregnancies with concurrent conditions and other indications for earlier delivery will also be excluded. 9. Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
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Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
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Duke University Perinatal Research Center
Durham, North Carolina, 27705, United States
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INOVA Fairfax Hospital
Falls Church, Virginia, 22042, United States
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Intermountain Healthcare
Murray, Utah, 84107, United States
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Ochsner Baptist
New Orleans, Louisiana, 70115, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Utah
Salt Lake City, Utah, 84132, United States
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Other studies related to the condition(s) this trial covers.
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