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40 weeks or 41? the delivery timing question for gestational diabetes

NCT ID NCT07831954

NEW Disease control Sponsor: Peking University Third Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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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 Results may not be published yet.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
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)
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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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether waiting until 41 weeks to induce labor leads to fewer cesarean deliveries than inducing at 40 weeks in first-time mothers with diet-controlled gestational diabetes. The trial enrolls 1,500 women who manage their blood sugar through diet and exercise alone. Participants are randomly assigned to either planned induction at 40 weeks or expectant management until 41 weeks, with both groups receiving routine care if labor starts on its own. The main outcome is the cesarean delivery rate, with other maternal and newborn health measures tracked through delivery and up to six weeks after birth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
timing of planned delivery (induction of labor at 40 weeks versus expectant management until 41 weeks)
What this could lead to
If waiting until 41 weeks proves safer, it could spare some women with diet-controlled gestational diabetes an early induction and its associated interventions. If earlier induction proves better, it could become the standard to reduce cesarean deliveries.
What could go wrong
The trial may find no meaningful difference between the two timing strategies, or the results may not apply to women with different types of gestational diabetes or those who need medication. Induction itself carries risks such as a longer labor or higher chance of cesarean, which the trial aims to measure.

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

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 40 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 18-40 years; * Singleton pregnancy; * Nulliparous; * Diagnosed with gestational diabetes mellitus (GDM) by oral glucose tolerance test (OGTT) at 24-28 weeks of gestation; * At screening/enrollment, classified as A1 GDM, defined as good glycemic control after exercise counseling and nutritional management. Both of the following criteria must be met: (1) No use of insulin or other glucose-lowering medications during pregnancy up to screening/enrollment, verified through medication orders in the hospital information system (HIS); and (2) The clinician assesses overall glycemic control during pregnancy as meeting target and explicitly documents A1 GDM in the outpatient medical record. * Provides written informed consent. Exclusion Criteria * Maternal factors: signs of labor; prelabor rupture of membranes; history of cesarean delivery or uterine surgery (e.g., myomectomy); clinically assessed pelvic contraction (e.g., pelvic outlet diameter ≤7.5 cm); cervical cerclage during the current pregnancy; planned cesarean delivery or any known contraindication to vaginal delivery; or severe pregnancy-related complications or comorbidities considered by the investigator to preclude tolerance of vaginal delivery, such as severe heart disease complicating pregnancy, intrahepatic cholestasis of pregnancy, hypertensive disorders of pregnancy, psychiatric disorders/cognitive impairment, autoimmune diseases, or severe anemia. * Fetal factors: non-cephalic presentation; intrauterine fetal demise; fetal distress; fetal structural malformations or chromosomal abnormalities; fetal growth restriction (ultrasound-estimated fetal weight below the 10th percentile); or large-for-gestational-age fetus (ultrasound-estimated fetal weight above the 90th percentile). * Amniotic fluid factors: oligohydramnios, defined as an amniotic fluid index (AFI) ≤5 cm or a maximum vertical pocket (MVP) ≤2 cm; or polyhydramnios, defined as an AFI ≥25 cm or an MVP ≥8 cm. * Placental factors: placenta previa, placenta accreta spectrum, vasa previa, or similar conditions. * Medication-related contraindications: contraindications to induction agents such as misoprostol or oxytocin, including asthma, glaucoma, a scarred uterus, or drug allergy/hypersensitivity.

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Conditions

The condition(s) this trial relates to.

gestational diabetes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes mellitus (GDM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100083, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.