The WAIT Trial: Waiting Versus Active Induction at Term in Women With A1 Gestational Diabetes Mellitus

Condition(s) studied

Investigational drug(s) / intervention(s)

Timing of Planned Delivery: Assignment to a planned delivery timing strategy: induction of labor at 40+0 weeks (allowable window: 39+6 to 40+0 weeks) or expectant management until induction at 41+0 weeks (allowable window: 41+0 to 41+1 weeks), unless spontaneous labor occurs earlier; spontaneous labor is managed according to routine obstetric care.

Study summary

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.

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.

Eligibility

Primary outcome measure(s)

• Cesarean delivery rate — From date of randomization until delivery, assessed up to 42 days postpartum
  The proportion of randomized participants who undergo cesarean delivery from randomization until delivery, calculated as: number of participants undergoing cesarean delivery / number of randomized participants × 100%. Cesarean delivery includes elective cesarean delivery, intrapartum cesarean delivery, non-elective cesarean delivery before labor onset for medical indications, including emergency cesarean delivery, and other cesarean deliveries performed for medical indications. This outcome will be derived from the "mode of delivery" field in the case report form. Cesarean delivery indications include failed induction of labor, dystocia or abnormal labor progression, nonreassuring fetal status, intrauterine infection, and other medical indications, as specified in the case report form.

Trial sites (1)

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