A Pilot Study of Induction at 39 Weeks to Reduce Cesarean in Low - Risk Women in China

Not Applicable

Recruiting

• Conditions: Cesarean Delivery

• Registration Number: NCT07082530
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-25
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-15
• Study First Posted: 2025-07-24
• Study Start: 2025-07-30
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-06
• Primary Completion: 2026-12-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1074

Inclusion Criteria

1. Age ≥18 years.
2. Singleton pregnancy or twin pregnancy reduced to singleton before 14 weeks.
3. Gestational age of 38 weeks 6 days or 39 weeks 0 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 favorable 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of cesarean section	Delivery day	The proportion of deliveries completed by cesarean section

Secondary Outcome Measures

Name	Time	Method
Composite incidence of severe neonatal morbidity and perinatal mortality	Hospital discharge (Day 2-3)	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	Delivery day	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	Delivery day	Cesarean performed within approximately 30 minutes due to immediate life-threatening conditions (e.g., uterine rupture, severe fetal distress)
Category 2 Emergency Cesarean Rate	Delivery day	Cesarean performed within 60-75 minutes due to urgent but not immediately life-threatening indications (e.g., progressive fetal distress, labor arrest)
Elective Cesarean Rate	Delivery day	Planned cesarean performed at or after 39 weeks in the absence of emergency conditions, meeting all of the following: 1. Surgery scheduled ≥24 hours before onset of labor; 2. No spontaneous contractions or rupture of membranes; 3. Clear medical indications (e.g., placenta previa, breech presentation) or maternal request.
Operative Vaginal Delivery	Delivery day	The rate of vaginal deliveries assisted with instruments such as forceps or vacuum.
Gestational Age at Delivery	Delivery day	Expressed in weeks and decimal days (e.g., 39 weeks + 5 days = 39.7 weeks)
Chorioamnionitis	Delivery day	Incidence of chorioamnionitis, defined as a clinical diagnosis before delivery as: maternal body temperature rises (\>38°C) with 1 or more of the following symptoms: 1. Maternal tachycardia (\>100 beats/min); 2. Fetal tachycardia (\>160 beats/min); 3. Uterine tenderness and irritability; 4. Purulent or malodorous amniotic fluid or vaginal discharge; 5. Maternal leukocytosis (white blood cell count \> 15000/mm3)
Third-or fourth-degree perineal laceration	Delivery day	The incidence of third-or fourth-degree perineal laceration
Time from Randomization to Delivery	Delivery day	Measured in hours
Postpartum hemorrhage	Hospital discharge (Day 2-3)	Refer to the ARRIVE cohort, defined as any of the following situations: 1. Transfusion; 2. Non-elective hysterectomy; 3. Use of two or more uterotonics other than oxytocin; 4. Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization and hypogastric ligation, balloon tamponade; 5. Curettage
Postpartum infection	Hospital discharge (Day 2-3)	Refer to the ARRIVE cohort, defined as any of the following situations: 1. Clinical diagnosis of endometritis; 2. Wound reopened for hematoma, seroma, infection or other reasons; 3. Cellulitis requiring antibiotics; 4. Pneumonia; 5. Pyelonephritis; 6. Bacteremia unknown source; 7. Septic pelvic thrombosis
ICU admission	Hospital discharge (Day 2-3)	The proportion of admission to the ICU
Maternal death	Hospital discharge (Day 2-3)	The incidence of maternal death
Preeclampsia/gestational hypertension	Hospital discharge (Day 2-3)	The incidence of preeclampsia or gestational hypertension diagnosed during labor
Maternal venous thromboembolism	Hospital discharge (Day 2-3)	Deep vein thrombosis or pulmonary embolism
Maternal pain	Hospital discharge (Day 2-3)	Median patient-reported pain outcomes with a 10-point Likert scale
Birth weight	Delivery day	The mean birth weight
Female gender	Delivery day	The proportion of female offspring in terms of physiological gender
Macrosomia	Delivery day	Birth weight \> 4000g
Incidence of large for gestational age	Delivery day	According to the infant's gender and gestational age, the birth weight exceeds the 90th percentile of infants of the same gestational age
Incidence of small for gestational age	Delivery day	According to the infant's gender and gestational age, the birth weight is less than the 10th percentile of infants of the same gestational age
Apgar scores at 5 min	Delivery day	Apgar score at 5 minutes after birth
Neonatal acidosis	Delivery day	The incidence of neonatal acidosis defined as umbilical artery blood pH \< 7.00
Shoulder dystocia	Delivery day	The incidence of shoulder dystocia
Hyperbilirubinemia	Hospital discharge (Day 2-3)	The incidence of hyperbilirubinemia requiring phototherapy or exchange transfusion
Transfusion of blood products or blood	Hospital discharge (Day 2-3)	The incidence of neonatal transfusion of blood products or blood
Hypoglycemia incidence	Hospital discharge (Day 2-3)	The incidence of hypoglycemia (blood glucose \< 35mg/L) requiring intravenous treatment
Neonatal intensive care unit (NICU) admission	Hospital discharge (Day 2-3)	The incidence of admission to the NICU
Physical measurement indicators	42 days and 6 months	Infant weight, length, head circumference, chest circumference, sitting height, upper arm circumference, subcutaneous fat, height-chest circumference index, crown-rump length/length
Growth balance indicators	42 days and 6 months	Weight-for-length, length-for-age, weight-for-age z scores of infants, calculated using the World Health Organization (WHO) tool, WHO Anthro Survey Analyser
Growth retardation	42 days and 6 months	Height standard deviation for age \< mean-2S or percentile method \< P3
Abnormal neurological examination	42 days and 6 months	The proportion of abnormal results in neurological examinations (hearing development, nerve reflexes)
Scores of Bayley Scales of Infant and Toddler Development	42 days and 6 months	Total score, cognitive scale score, language scale score, motor scale score, social-emotional scale score, adaptive behavior scale score
Scores of Ages & Stages Questionnaires®, Third Edition (ASQ-3)	42 days and 6 months	Total score, communication domain score, gross motor domain score, fine motor domain score, problem-solving domain score, personal-social domain score
Gut microbiota development	Meconium, first 48 hours, 7 days, 6 weeks and 6 months	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	Meconium, first 48 hours, 7 days, 6 weeks and 6 months	Non-targeted metabolomic macroscopic differences, core metabolomic differences (including tryptophan, fatty acids), and differences in gut microbiota metabolites
Cord blood metabolomic characteristics	Delivery day	Assessment of non-targeted metabolomic macroscopic differences and core metabolomic differences (including tryptophan, fatty acids) in cord blood plasma
Cord blood proteomic characteristics	Delivery day	Analysis of the proteomic characteristics of cord blood whole blood to trace back the health status during the fetal period
Time from randomization to delivery	Delivery day	Median time from randomization to birth of the fetus, measured in hours
Use of epidural analgesia	Delivery day	Rate of epidural analgesia use
Time spent in the delivery room	Delivery day	Median time spent in the delivery room, measured in hours
Length of postpartum hospital stay	Hospital discharge (Day 2-3)	Median postpartum length of stay, measured in hours
Neonatal length of hospital stays	Hospital discharge (Day 2-3)	Median neonatal hospital stays, measured in hours
Pre-insurance hospitalization cost	Hospital discharge (Day 2-3)	Total hospitalization cost during delivery, before insurance reimbursement
Out-of-pocket hospitalization cost	Hospital discharge (Day 2-3)	Out-of-pocket cost incurred during delivery hospitalization

Trial Locations

Locations (1)

Women's Hospital School of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China