A RCT of Labor Induction at 39 Weeks in Low - Risk Women in China

NCT07082530 | Recruiting DMC

• 1 other identifier: IRB-20250211-R
• Study Type: interventional
• Target: 1,074
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are committed to identifying the optimal timing of delivery for low-risk pregnancies. While current guidelines typically recommend induction at 41 weeks, emerging evidence suggests that elective induction at 39 weeks may lead to improved maternal and neonatal outcomes. The U.S.-based ARRIVE trial demonstrated that induction at 39 weeks significantly reduced cesarean delivery rates compared to expectant management, and a similar randomized controlled trial (French-ARRIVE) is ongoing in France. However, population-specific evidence for the Chinese population remains lacking. This study is designed to establish a prospective cohort of low-risk pregnant women in China, comparing the effects of induction at 39 weeks, induction at 41 weeks, and expectant management on cesarean section rates and other maternal and neonatal outcomes. In addition, multi-omics technologies will be employed to analyze cord blood samples-including metabolomics and proteomics-to identify early biomarkers potentially associated with long-term child health. The study will begin with a pilot phase to assess feasibility and inform operational strategies for large-scale implementation. The ultimate goal of this project is to generate evidence tailored to the Chinese population to support more individualized decision-making, improve clinical outcomes, and enhance maternal and neonatal safety.

Conditions

Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• Incidence of cesarean section

  The proportion of deliveries completed by cesarean section

  Delivery day

Secondary Outcomes (41)

• Composite incidence of severe neonatal morbidity and perinatal mortality

  Hospital discharge (Day 2-3)

• Emergency Cesarean Rate

  Delivery day

• Category 1 Emergency Cesarean Rate

  Delivery day

• Category 2 Emergency Cesarean Rate

  Delivery day

• Elective Cesarean Rate

  Delivery day

Other Outcomes (4)

• Gut microbiota development

  Meconium, first 48 hours, 7 days, 3 weeks, 6 weeks, 3 months, and 6 months

• Fecal metabolomic characteristics

  Meconium, first 48 hours, 7 days, 3 weeks, 6 weeks, 3 months, and 6 months

• Cord blood metabolomic characteristics

  Delivery day

Study Arms (2)

Induction group

EXPERIMENTAL

Labor induction at 39 weeks 0 days to 39 weeks 4 days

Procedure: Labor Induction at 39 Weeks

Control group

ACTIVE COMPARATOR

Expectant management until spontaneous labor or induction at 41 weeks

Procedure: Expectant management

Interventions

Labor Induction at 39 Weeks PROCEDURE

Labor induction at 39 weeks 0 days to 39 weeks 4 days

Induction group

Expectant management PROCEDURE

Expectant management until spontaneous labor or induction at 41 weeks.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Singleton pregnancy or twin pregnancy reduced to singleton before 14 weeks.
• Gestational age between 38 weeks 4 days or 39 weeks 3 days at randomization.
• Eligible for vaginal delivery with a desire for vaginal birth.
• Reliable gestational age determination.
• Maternal and fetal conditions assessed as favorable by at least two senior obstetricians, with no indications requiring delivery before 41 weeks.
• Ability to understand study information and provide informed consent.

You may not qualify if:

• First-trimester ultrasound estimate \>13 weeks 6 days.
• Planned induction before 41 weeks.
• Planned cesarean delivery or contraindications to vaginal delivery.
• Already delivered, in labor, or ruptured membranes at enrollment.
• Placenta previa, vasa previa, placenta accreta, or placental abruption.
• Contraindications to induction (e.g., cervical cancer, history of uterine rupture, genital tract malformations, abnormal fetal position, cord prolapse).
• Active vaginal bleeding exceeding spotting.
• History of cesarean delivery or uterine/cervical surgery.
• Cervical cerclage during this pregnancy.
• Maternal conditions not suitable for expectant management beyond 39 weeks (e.g., pregestational diabetes, gestational diabetes requiring insulin, hypertensive disorders, intrahepatic cholestasis of pregnancy).
• Fetal conditions not suitable for expectant management beyond 39 weeks (e.g., fetal death, major anomalies, growth restriction, macrosomia, anemia, oligohydramnios, polyhydramnios).
• Maternal infections or positive screenings for sexually transmitted pathogens or group B Streptococcus.
• Planned delivery at a non-study facility.
• Participation in another intervention study affecting delivery management.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Dan Zhang, Ph. D.

  Key Laboratory of Reproductive Genetics, Women's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huajing Gao, MD Candidate

CONTACT

86+18867114750; huajingg@zju.edu.cn

Study Design

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

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 24, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CN (1)