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

RecruitingNAAges 18 Years - anyFemaleWomen's Hospital School Of Medicine Zhejiang Univ…
NCT07082530 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥18 years. 2. Singleton pregnancy or twin pregnancy reduced to singleton before 14 weeks. 3. Gestational age between 38 weeks 4 days or 38 weeks 6 days at randomization. 4. Eligible for vaginal delivery with a desire for vaginal birth. 5. Reliable gestational age determination. 6. Maternal and fetal conditions assessed as low-risk by at least two senior obstetricians, with no indications requiring delivery before 41 weeks. 7. Ability to understand study information and provide informed consent. Exclusion Criteria: 1. First-trimester ultrasound estimate \>13 weeks 6 days. 2. Planned induction before 41 weeks. 3. Planned cesarean delivery or contraindications to vaginal delivery. 4. Already delivered, in labor, or ruptured membranes at enrollment. 5. Placenta previa, vasa previa, placenta accreta, or placental abruption. 6. Contraindications to induction (e.g., cervical cancer, history of uterine rupture, genital tract malformations, abnormal fetal position, cord prolapse). 7. Active vaginal bleeding exceeding spotting. 8. History of cesarean delivery or uterine/cervical surgery. 9. Cervical cerclage during this pregnancy. 10. Maternal conditions not suitable for expectant management beyond 39 weeks (e.g., pregestational diabetes, gestational diabetes requiring insulin, hypertensive disorders, intrahepatic cholestasis of pregnancy). 11. Fetal conditions not suitable for expectant management beyond 39 weeks (e.g., fetal death, major anomalies, growth restriction, macrosomia, anemia, oligohydramnios, polyhydramnios). 12. Maternal infections or positive screenings for sexually transmitted pathogens or group B Streptococcus. 13. Planned delivery at a non-study facility. 14. Participation in another intervention study affecting delivery management.
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What it tests

  • Labor Induction at 39 Weeks
  • Expectant management
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Where

1 site
Women's Hospital School of Medicine Zhejiang University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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