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Recruiting NCT07082530

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

No phase Interventional Cesarean Delivery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Labor Induction at 39 Weeks, Expectant management.
Who it may be relevant to
Registry conditions: Cesarean Delivery. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Labor Induction at 39 Weeks
    Labor induction at 39 weeks 0 days to 39 weeks 4 days
  • Procedure Expectant management
    Expectant management until spontaneous labor or induction at 41 weeks.

Primary outcome measures

  • Incidence of cesarean section [Time frame: Delivery day]
Secondary outcome measures (12)
  • Composite incidence of severe neonatal morbidity and perinatal mortality [Time frame: Hospital discharge (Day 2-3)]
  • Emergency Cesarean Rate [Time frame: Delivery day]
  • Category 1 Emergency Cesarean Rate [Time frame: Delivery day]
  • Category 2 Emergency Cesarean Rate [Time frame: Delivery day]
  • Elective Cesarean Rate [Time frame: Delivery day]
  • Operative Vaginal Delivery [Time frame: Delivery day]
  • Gestational Age at Delivery [Time frame: Delivery day]
  • Chorioamnionitis [Time frame: Delivery day]
  • Third-or fourth-degree perineal laceration [Time frame: Delivery day]
  • Postpartum hemorrhage [Time frame: Hospital discharge (Day 2-3)]
  • Postpartum infection [Time frame: Hospital discharge (Day 2-3)]
  • ICU admission [Time frame: Hospital discharge (Day 2-3)]

Eligibility criteria

Inclusion criteria

  • 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.
  • Reliable gestational age determination.
  • Maternal and fetal conditions assessed as low-risk by at least two senior obstetricians, with no indications requiring delivery before 41 weeks.
  • Ability to understand study information and provide informed consent.

Exclusion criteria

  • 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.
  • Placenta previa, vasa previa, placenta accreta, or placental abruption.
  • Contraindications to induction (e.g., cervical cancer, history of uterine rupture, genital tract malformations, abnormal fetal position, 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 (e.g., pregestational diabetes, gestational diabetes requiring insulin, hypertensive disorders, intrahepatic cholestasis of pregnancy).
  • Fetal conditions not suitable for expectant management beyond 39 weeks (e.g., fetal death, major anomalies, growth restriction, macrosomia, anemia, oligohydramnios, polyhydramnios).
  • Maternal infections or positive screenings for sexually transmitted pathogens or group B Streptococcus.
  • Planned delivery at a non-study facility.
  • Participation in another intervention study affecting delivery management.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Women's Hospital School of Medicine Zhejiang University — Hangzhou

Identifiers

NCT: NCT07082530 · IRB-20250211-R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗