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.
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.
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.
Parallel
Labor Induction at 39 Weeks
Procedure/SurgeryLabor induction at 39 weeks 0 days to 39 weeks 4 days
Expectant management
Procedure/SurgeryExpectant management until spontaneous labor or induction at 41 weeks.
Incidence of cesarean section
The proportion of deliveries completed by cesarean section
Composite incidence of severe neonatal morbidity and perinatal mortality
The composite incidence of any of the following: 1. Antepartum, intrapartum, or neonatal death 2. Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiorespiratory support within first 72 hours 3. Apgar ≤ 3 at 5 minutes 4. Neonatal encephalopathy 5. Seizures 6. Sepsis (presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebral spinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection). 7. Pneumonia confirmed by X-ray or positive blood culture. 8. Meconium aspiration syndrome 9. Birth trauma (bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, facial nerve injury) 10. Intracranial hemorrhage or subgaleal hemorrhage 11. Hypotension requiring pressor support
Emergency Cesarean Rate
Cesarean delivery performed immediately or shortly after clinical decision due to imminent threat to the life of the mother or fetus
Category 1 Emergency Cesarean Rate
Cesarean performed within approximately 30 minutes due to immediate life-threatening conditions (e.g., uterine rupture, severe fetal distress)
Category 2 Emergency Cesarean Rate
Cesarean performed within 60-75 minutes due to urgent but not immediately life-threatening indications (e.g., progressive fetal distress, labor arrest)
Gut microbiota development
Microbiota richness, dominant species, species transferred from mother to child, sub-group functional trajectory changes of the dominant species in offspring, and the transmissibility of species number and function
Fecal metabolomic characteristics
Non-targeted metabolomic macroscopic differences, core metabolomic differences (including tryptophan, fatty acids), and differences in gut microbiota metabolites
Cord blood metabolomic characteristics
Assessment of non-targeted metabolomic macroscopic differences and core metabolomic differences (including tryptophan, fatty acids) in cord blood plasma
Cord blood proteomic characteristics
Analysis of the proteomic characteristics of cord blood whole blood to trace back the health status during the fetal period
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