Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07082530

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

Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2026-02-25

1074

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Singleton pregnancy or twin pregnancy reduced to singleton before 14 weeks
  • Gestational age between 38 weeks 4 days and 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
Not Eligible

You will not qualify if you...

  • First-trimester ultrasound estimate greater than 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 such as cervical cancer, history of uterine rupture, genital tract malformations, abnormal fetal position, or 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, including pregestational diabetes, insulin-dependent gestational diabetes, hypertensive disorders, or intrahepatic cholestasis of pregnancy
  • Fetal conditions not suitable for expectant management beyond 39 weeks, including fetal death, major anomalies, growth restriction, macrosomia, anemia, oligohydramnios, or polyhydramnios
  • Maternal infections or positive screenings for sexually transmitted infections or group B Streptococcus
  • Planned delivery at a non-study facility
  • Participation in another intervention study affecting delivery management

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

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Research Team

H

Huajing Gao, MD Candidate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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