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

Study acronym: LIRIC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 30, 2026 → Dec 30, 2027
See other at-risk trials from Women's Hospital School Of Medicine Zhejiang University

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Dec 30, 2026 to Dec 30, 2027
    • Study completion pushed from Jun 30, 2027 to Jun 30, 2028
    v5
  2. Minor Eligibility criteria revisedv4
  3. Minor Eligibility criteria revised
    • Secondary endpoints: 46 to 41
    • Study title shortened, about 3 words
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2025 to Jul 30, 2025
    • Site details revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07082530
Lead Sponsor Women's Hospital School Of Medicine Zhejiang University
Conditions
(from sponsor)
Cesarean Delivery
Enrollment 1,074 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov