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Timing delivery for gestational diabetes: What's the safest week?

NCT ID NCT05515744

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

304 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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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

  • Duke University Perinatal Research Center

    Durham, North Carolina, 27705, United States

  • INOVA Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Intermountain Healthcare

    Murray, Utah, 84107, United States

  • Ochsner Baptist

    New Orleans, Louisiana, 70115, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

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