A Pilot Study of Induction at 39 Weeks to Reduce Cesarean in Low - Risk Women in China

NCT ID: NCT07082530

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1074 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction group

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

Group Type: EXPERIMENTAL

Labor Induction at 39 Weeks

Intervention Type: PROCEDURE

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

Control group

Expectant management until spontaneous labor or induction at 41 weeks

Group Type: ACTIVE_COMPARATOR

Expectant management

Intervention Type: PROCEDURE

Expectant management until spontaneous labor or induction at 41 weeks.

Interventions

Labor Induction at 39 Weeks

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

Intervention Type: PROCEDURE

Expectant management

Expectant management until spontaneous labor or induction at 41 weeks.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years.

2. Singleton pregnancy or twin pregnancy reduced to singleton before 14 weeks.

3. Gestational age of 38 weeks 6 days or 39 weeks 0 days at randomization.

4. Eligible for vaginal delivery with a desire for vaginal birth.

5. Reliable gestational age determination.

6. Maternal and fetal conditions assessed as favorable by at least two senior obstetricians, with no indications requiring delivery before 41 weeks.

7. Ability to understand study information and provide informed consent.

Exclusion Criteria

1. First ultrasound estimate >13 weeks 6 days.

2. Planned induction before 41 weeks.

3. Planned cesarean delivery or contraindications to vaginal delivery.

4. Already delivered, in labor, or ruptured membranes at enrollment.

5. Placenta previa, vasa previa, placenta accreta, or placental abruption.

6. Contraindications to induction (e.g., cervical cancer, history of uterine rupture, genital tract malformations, abnormal fetal position, cord prolapse).

7. Active vaginal bleeding exceeding spotting.

8. History of cesarean delivery or uterine/cervical surgery.

9. Cervical cerclage during this pregnancy.

10. Maternal conditions not suitable for expectant management beyond 39 weeks (e.g., pregestational diabetes, gestational diabetes requiring insulin, hypertensive disorders, intrahepatic cholestasis of pregnancy).

11. Fetal conditions not suitable for expectant management beyond 39 weeks (e.g., fetal death, major anomalies, growth restriction, macrosomia, anemia, oligohydramnios, polyhydramnios).

12. Maternal infections or positive screenings for sexually transmitted pathogens or group B Streptococcus.

13. Planned delivery at a non-study facility.

14. Participation in another intervention study affecting delivery management.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Zhang, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huajing Gao, MD Candidate

Role: CONTACT

huajingg@zju.edu.cn

86+18867114750

Facility Contacts

Huajing Gao, MD Candidate

Role: primary

huajingg@zju.edu.cn

86+18867114750

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB-20250211-R

Identifier Type: -

Identifier Source: org_study_id