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

NCT07831954 | Not Yet Recruiting DMC

• 2 other identifiers: M202503212023YFC2705900
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

A1 Gestational Diabetes Mellitus; Timing of Delivery; Induction of Labor; Expectant Management; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Cesarean delivery rate

  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, and other medical indications, as specified in the case report form.

  From date of randomization until delivery, assessed up to 42 days postpartum

Secondary Outcomes (9)

• Postpartum blood loss

  From delivery through 24 hours postpartum

• Macrosomia rate

  At birth

• Perinatal mortality

  From date of randomization until 28 days after birth

• Neonatal respiratory support

  From date of birth until neonatal hospital discharge, assessed up to 42 days postpartum

• Other secondary maternal outcomes

  From date of randomization until 42 days postpartum, as applicable.

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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.

Behavioral: Timing of Planned Delivery

Control Arm

ACTIVE COMPARATOR

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.

Behavioral: Timing of Planned Delivery

Interventions

Timing of Planned Delivery BEHAVIORAL

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.

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Participants' eligibility is based on biological sex because pregnancy and childbirth-related outcomes are assessed.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Shenzhen Baoan Women's and Children's Hospital: collaborator
• Fujian Maternity and Child Health Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

Related Publications (15)

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

  PMID: 29370047 RESULT

• Simjak P, Krejci H, Hornova M, Mraz M, Parizek A, Krsek M, Haluzik M, Anderlova K. Establishing the Optimal Time for Induction of Labor in Women with Diet-Controlled Gestational Diabetes Mellitus: A Single-Center Observational Study. J Clin Med. 2022 Oct 29;11(21):6410. doi: 10.3390/jcm11216410.

  PMID: 36362638 RESULT

• Melamed N, Ray JG, Geary M, Bedard D, Yang C, Sprague A, Murray-Davis B, Barrett J, Berger H. Induction of labor before 40 weeks is associated with lower rate of cesarean delivery in women with gestational diabetes mellitus. Am J Obstet Gynecol. 2016 Mar;214(3):364.e1-8. doi: 10.1016/j.ajog.2015.12.021.

  PMID: 26928149 RESULT

• Vitner D, Hiersch L, Ashwal E, Shmueli A, Yogev Y, Aviram A. Induction of labor versus expectant management for gestational diabetes mellitus at term. Arch Gynecol Obstet. 2019 Jul;300(1):79-86. doi: 10.1007/s00404-019-05171-3. Epub 2019 May 7.

  PMID: 31065804 RESULT

• Hong J, Atkinson J, Roddy Mitchell A, Tong S, Walker SP, Middleton A, Lindquist A, Hastie R. Comparison of Maternal Labor-Related Complications and Neonatal Outcomes Following Elective Induction of Labor at 39 Weeks of Gestation vs Expectant Management: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023 May 1;6(5):e2313162. doi: 10.1001/jamanetworkopen.2023.13162.

  PMID: 37171818 RESULT

• Papalia N, D'Souza RD, Hobson SR. Optimal timing of labour induction in contemporary clinical practice. Best Pract Res Clin Obstet Gynaecol. 2022 Mar;79:18-26. doi: 10.1016/j.bpobgyn.2021.12.002. Epub 2021 Dec 16.

  PMID: 35000808 RESULT

• Boulvain M, Senat MV, Perrotin F, Winer N, Beucher G, Subtil D, Bretelle F, Azria E, Hejaiej D, Vendittelli F, Capelle M, Langer B, Matis R, Connan L, Gillard P, Kirkpatrick C, Ceysens G, Faron G, Irion O, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial. Lancet. 2015 Jun 27;385(9987):2600-5. doi: 10.1016/S0140-6736(14)61904-8. Epub 2015 Apr 8.

  PMID: 25863654 RESULT

• McElduff A, Cheung NW, McIntyre HD, Lagstrom JA, Oats JJ, Ross GP, Simmons D, Walters BN, Wein P; Australasian Diabetes in Pregnancy Society. The Australasian Diabetes in Pregnancy Society consensus guidelines for the management of type 1 and type 2 diabetes in relation to pregnancy. Med J Aust. 2005 Oct 3;183(7):373-7.

  PMID: 16201957 RESULT

• Kitzmiller JL, Block JM, Brown FM, Catalano PM, Conway DL, Coustan DR, Gunderson EP, Herman WH, Hoffman LD, Inturrisi M, Jovanovic LB, Kjos SI, Knopp RH, Montoro MN, Ogata ES, Paramsothy P, Reader DM, Rosenn BM, Thomas AM, Kirkman MS. Managing preexisting diabetes for pregnancy: summary of evidence and consensus recommendations for care. Diabetes Care. 2008 May;31(5):1060-79. doi: 10.2337/dc08-9020. No abstract available.

  PMID: 18445730 RESULT

• Hoffman L, Nolan C, Wilson JD, Oats JJ, Simmons D. Gestational diabetes mellitus--management guidelines. The Australasian Diabetes in Pregnancy Society. Med J Aust. 1998 Jul 20;169(2):93-7. doi: 10.5694/j.1326-5377.1998.tb140192.x. No abstract available.

  PMID: 9700346 RESULT

• Greuter MJ, van Emmerik NM, Wouters MG, van Tulder MW. Quality of guidelines on the management of diabetes in pregnancy: a systematic review. BMC Pregnancy Childbirth. 2012 Jun 28;12:58. doi: 10.1186/1471-2393-12-58.

  PMID: 22741571 RESULT

• ACOG Committee on Practice Bulletins. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists. Number 60, March 2005. Pregestational diabetes mellitus. Obstet Gynecol. 2005 Mar;105(3):675-85. doi: 10.1097/00006250-200503000-00049. No abstract available.

  PMID: 15738045 RESULT

• Alejandro EU, Mamerto TP, Chung G, Villavieja A, Gaus NL, Morgan E, Pineda-Cortel MRB. Gestational Diabetes Mellitus: A Harbinger of the Vicious Cycle of Diabetes. Int J Mol Sci. 2020 Jul 15;21(14):5003. doi: 10.3390/ijms21145003.

  PMID: 32679915 RESULT

• Popova PV, Pustozerov EA, Tkachuk AS, Grineva EN. Improving nutrition for the prevention of gestational diabetes: Current status and perspectives. World J Diabetes. 2021 Sep 15;12(9):1494-1506. doi: 10.4239/wjd.v12.i9.1494.

  PMID: 34630902 RESULT

• Kautzky-Willer A, Winhofer Y, Kiss H, Falcone V, Berger A, Lechleitner M, Weitgasser R, Harreiter J. [Gestational diabetes mellitus (Update 2023)]. Wien Klin Wochenschr. 2023 Jan;135(Suppl 1):115-128. doi: 10.1007/s00508-023-02181-9. Epub 2023 Apr 20. German.

  PMID: 37101032 RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Yuan Wei, PhD, MD

CONTACT

01082267852; weiyuanbysy@163.com

Tianchen Wu, PhD

CONTACT

wtc17@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)