Actively Recruiting
Labor Induction in Low-risk Women at 39 Weeks of Gestation: A Randomized Trial in China
Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2026-05-19
1074
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the best timing for labor induction in low-risk pregnant women in China. This trial compares induction at 39 weeks, induction at 41 weeks, and expectant management to see which approach leads to fewer cesarean deliveries and better outcomes for mothers and babies. The study will also use advanced techniques to analyze cord blood for early markers linked to child health. It starts with a pilot phase to test feasibility and plan for a larger study. Participants will be randomly assigned to one of two groups: induction of labor between 39 weeks 0 days and 39 weeks 4 days, or expectant management until spontaneous labor or induction at 41 weeks. The trial focuses on women assessed as low-risk for delivery before 41 weeks. The study aims to generate evidence specific to the Chinese population to support safer and more personalized care. During the study, women will be monitored for delivery outcomes, including cesarean rates and maternal and newborn health indicators. Researchers will collect data on various maternal and neonatal complications, hospital stays, and costs. Follow-up assessments will occur at hospital discharge and at 6 weeks and 6 months after birth, including developmental evaluations of the child. The main outcome measured is the rate of cesarean delivery on the day of birth.
CONDITIONS
Brief Title
A RCT of Labor Induction at 39 Weeks in Low - Risk Women in China
Who Can Participate
Eligibility Criteria
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 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
- No indications requiring delivery before 41 weeks
- Ability to understand study information and provide informed consent
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 unsuitable for expectant management beyond 39 weeks like pregestational diabetes, insulin-requiring gestational diabetes, hypertensive disorders, or intrahepatic cholestasis of pregnancy
- Fetal conditions unsuitable 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 pathogens or group B Streptococcus
- Planned delivery at a non-study facility
- Participation in another intervention study affecting delivery management
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - From 39 weeks 0 days to delivery
Participants undergo either labor induction at 39 weeks or expectant management until spontaneous labor or induction at 41 weeks.
1 to 2 visits depending on timing of labor onset
Duration - Up to 6 months postpartum
Participants and newborns are monitored for health outcomes up to 6 months after delivery.
Follow-up visits at hospital discharge (Day 2-3), 6 weeks, and 6 months postpartum
Trial Site Locations
Total: 1 location
1
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
H
Huajing Gao, MD Candidate
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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