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Comparing labor induction at 40 weeks with waiting until 41 weeks in gestational diabetes

Compares two delivery timing plans in first-time mothers with diet-controlled gestational diabetes.

Key facts

Who runs it
Peking University Third Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
The WAIT Trial: Waiting Versus Active Induction at Term in Women With A1 Gestational Diabetes Mellitus
Status
Not yet recruiting
People taking part
1,500 people, planned
Started
1 Oct 2026
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Timing of Planned Delivery
Record updated
22 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women pregnant with their first baby who have diet-controlled gestational diabetes (A1 GDM) and plan a vaginal birth. It compares starting labor at 40 weeks with waiting until 41 weeks.

Age
18 to 40 years
Sex
Women only
Disease stage
Pregnancy with one baby, first birth. Gestational diabetes found by an oral glucose tolerance test (OGTT) at 24-28 weeks. Blood sugar must be on target with diet and exercise only (A1 GDM).
Earlier treatment
No insulin or other glucose-lowering medicines during this pregnancy.
Biomarker or test result
Gestational diabetes diagnosed by oral glucose tolerance test (OGTT).

Main reasons for not taking part

  • Labor already started, or waters broken before labor
  • Past cesarean or womb surgery through the muscle wall, or a planned cesarean
  • Serious pregnancy problems such as high blood pressure in pregnancy, liver cholestasis, severe heart disease or severe anemia
  • Baby not head-down, baby too small or too large, birth defects, or too little or too much amniotic fluid
  • Placenta problems (such as placenta previa), or cannot have misoprostol or oxytocin (for example asthma, glaucoma, allergy)

This trial only enrols pregnant participants. The registry sentence this rests on: * Singleton pregnancy;

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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 A1 GDM can be clearly identified through medical record information
  • Provides written informed consent

Who cannot take part

  • Maternal factors: signs of labor (regular progressive uterine contractions accompanied by progressive cervical effacement, cervical dilation and fetal descent); prelabor rupture of membranes; history of cesarean delivery or uterine surgery penetrating the myometrium (e.g., myomectomy; hysteroscopy, induced-abortion and other non-myometrial-penetrating surgeries are excluded); clinically assessed pelvic contraction; 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
  • Placental factors: placenta previa, vasa previa, placenta accreta spectrum, or similar conditions
  • Medication-related contraindications: contraindications to cervical ripening or labor-inducing agents including misoprostol and oxytocin, such as asthma, glaucoma, scarred uterus, or hypersensitivity to above-mentioned drugs
  • Fetal factors: non-cephalic presentation; intrauterine fetal demise; fetal distress; fetal structural malformations, chromosomal abnormalities, or other related anomalies; fetal growth restriction (pathologically driven failure of the fetus to reach its genetically-determined growth potential due to maternal, fetal or placental disorders, most commonly manifested as ultrasound-estimated fetal weight or abdominal circumference below the 10th percentile for corresponding gestational age); or large-for-gestational-age fetus (ultrasound-estimated fetal weight above the 90th percentile for corresponding gestational age)
  • Amniotic fluid factors: oligohydramnios, defined as an amniotic fluid index (AFI) ≤5 cm or a deepest vertical pocket (DVP) ≤2 cm; or polyhydramnios, defined as an AFI ≥25 cm or a DVP ≥8 cm

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 40 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

This multicenter, open-label, superiority randomized controlled trial will evaluate whether delaying planned induction from 40 weeks to 41 weeks improves delivery outcomes in women with A1 gestational diabetes mellitus (A1 GDM). The study is designed to enroll 1,500 eligible women (750 per group), all of whom are planned for vaginal delivery.

Read full original descriptionShow less

Eligible participants are women aged 18-40 years with singleton pregnancy and who are primiparous. GDM will be diagnosed using OGTT at 24-28 weeks, and participants must meet criteria for A1 GDM, meaning blood glucose is controlled with diet and exercise only (no insulin or other glucose-lowering medications during pregnancy). After providing written informed consent, participants will be randomized 1:1 to one of two pre-specified induction strategies.

Control group (planned induction at 40 weeks): Participants will have planned induction at 40+0 weeks (time window 39+6 to 40+0). If spontaneous labor occurs before or during the window, obstetric management will follow routine clinical practice. If labor has not started by the end of the window, induction will be performed according to the protocol.

Intervention group (expectant management until 41 weeks): Participants will be managed expectantly until 41+0 weeks with planned induction in the 41+0 to 41+1 weeks window. If spontaneous labor occurs before or during the window, routine obstetric management will be used. If labor has not started by the end of the window, induction will be performed according to the protocol.

Participants will be followed from randomization until delivery and hospital discharge, with selected outcomes followed up to postpartum day 42. The primary outcome is the cesarean delivery rate. Secondary outcomes include maternal outcomes such as postpartum hemorrhage and other obstetric complications, neonatal/perinatal outcomes including perinatal death, and need for respiratory support, as well as selected health-economic and patient-reported outcomes. All participating centers will apply standardized procedures for screening, monitoring, induction methods, and data collection. An independent Data and Safety Monitoring Board (DSMB) and a blinded Clinical Endpoint Committee will monitor safety and validate the primary outcome.

The trial is expected to be completed within approximately 18 months after initiation of recruitment, and the results will provide high-quality evidence to inform timing of delivery for women with A1 GDM in China.

The 2 groups in the trial

  • Experimental ArmTreatment being tested

    Pregnant women in this arm will receive expectant management until 41+0 weeks (time window: 41+0-41+1 weeks). Routine obstetric care will be provided if spontaneous labor occurs. Labor induction will be conducted for those without spontaneous labor.

    Treatment: Timing of Planned Delivery

  • Control ArmExisting treatment, for comparison

    Pregnant women in this arm will receive planned labor induction at 40+0 weeks (time window: 39+6-40+0 weeks). Routine obstetric care will be provided if spontaneous labor occurs. Labor induction will be conducted for those without spontaneous labor.

    Treatment: Timing of Planned Delivery

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Induction of Labor at 40 Weeks Versus Expectant Management Until 41 Weeks in Women With A1 Gestational Diabetes Mellitus: A Multicenter, Open-Label, Superiority Randomized Controlled Trial
Plain-language title
Comparing labor induction at 40 weeks with waiting until 41 weeks in gestational diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from NCT07831954, who can take part
Record updated
22 October 2026