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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 years.

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

Gestational age between 38 weeks 4 days or 38 weeks 6 days at randomization.

Eligible for vaginal delivery with a desire for vaginal birth.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Labor Induction at 39 Weeks
  • Expectant management

Treatment groups

1,074 Participants
are divided into 2 treatment groups