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RecruitingNCT07082530

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

Labor Induction in Low-risk Women at 39 Weeks of Gestation: A Randomized Trial in China

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
1,074 (estimated)
Sponsor
Women's Hospital School Of Medicine Zhejiang University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDURELabor Induction at 39 WeeksLabor induction at 39 weeks 0 days to 39 weeks 4 days
PROCEDUREExpectant managementExpectant management until spontaneous labor or induction at 41 weeks.

Timeline

Start date
2025-07-30
Primary completion
2026-12-30
Completion
2027-06-30
First posted
2025-07-24
Last updated
2026-02-25

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07082530. Inclusion in this directory is not an endorsement.