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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Incidence of cesarean section [Срок оценки: Delivery day]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Women's Hospital School of Medicine Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07082530 · IRB-20250211-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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