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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction group | Experimental | Labor induction at 39 weeks 0 days to 39 weeks 4 days |
|
| Control group | Active Comparator | Expectant management until spontaneous labor or induction at 41 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labor Induction at 39 Weeks | Procedure | Labor induction at 39 weeks 0 days to 39 weeks 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cesarean section | The proportion of deliveries completed by cesarean section | Delivery day |
| Measure | Description | Time Frame |
|---|---|---|
| Composite incidence of severe neonatal morbidity and perinatal mortality | The composite incidence of any of the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Meconium, first 48 hours, 7 days, 3 weeks, 6 weeks, 3 months, and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huajing Gao, MD Candidate | Contact | 86+18867114750 | huajingg@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dan Zhang, Ph. D. | Key Laboratory of Reproductive Genetics, Women's Hospital, Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2026 | May 14, 2026 | Prot_SAP_006.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2026 | Feb 22, 2026 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Expectant management | Procedure | Expectant management until spontaneous labor or induction at 41 weeks. |
|
| Hospital discharge (Day 2-3) |
| Emergency Cesarean Rate | Cesarean delivery performed immediately or shortly after clinical decision due to imminent threat to the life of the mother or fetus | Delivery day |
| Category 1 Emergency Cesarean Rate | Cesarean performed within approximately 30 minutes due to immediate life-threatening conditions (e.g., uterine rupture, severe fetal distress) | Delivery day |
| 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) | Delivery day |
| Elective Cesarean Rate | Planned cesarean performed at or after 39 weeks in the absence of emergency conditions, meeting all of the following:
| Delivery day |
| Operative Vaginal Delivery | The rate of vaginal deliveries assisted with instruments such as forceps or vacuum. | Delivery day |
| Gestational Age at Delivery | Expressed in weeks and decimal days (e.g., 39 weeks + 5 days = 39.7 weeks) | Delivery day |
| Chorioamnionitis | Incidence of chorioamnionitis, defined as a clinical diagnosis before delivery as: maternal body temperature rises (>38°C) with 2 or more of the following symptoms:
| Delivery day |
| Third-or fourth-degree perineal laceration | The incidence of third-or fourth-degree perineal laceration | Delivery day |
| Postpartum hemorrhage | Refer to the ARRIVE cohort, defined as any of the following situations:
| Hospital discharge (Day 2-3) |
| Postpartum infection | Refer to the ARRIVE cohort, defined as any of the following situations:
| Hospital discharge (Day 2-3) |
| ICU admission | The proportion of admission to the ICU | Hospital discharge (Day 2-3) |
| Maternal death | The incidence of maternal death | Hospital discharge (Day 2-3) |
| Preeclampsia/gestational hypertension | The incidence of preeclampsia or gestational hypertension diagnosed during labor | Hospital discharge (Day 2-3) |
| Maternal venous thromboembolism | Deep vein thrombosis or pulmonary embolism | Hospital discharge (Day 2-3) |
| Maternal pain | Median patient-reported pain outcomes with a 10-point Likert scale | Hospital discharge (Day 2-3) |
| Birth weight | The mean birth weight | Delivery day |
| Female gender | The proportion of female offspring in terms of physiological gender | Delivery day |
| Macrosomia | Birth weight > 4000g | Delivery day |
| Incidence of large for gestational age | According to the infant's gender and gestational age, the birth weight exceeds the 90th percentile of infants of the same gestational age | Delivery day |
| Incidence of small for gestational age | 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 | Delivery day |
| Apgar scores at 5 min | Apgar score at 5 minutes after birth | Delivery day |
| Neonatal acidosis | The incidence of neonatal acidosis defined as umbilical artery blood pH < 7.10 | Delivery day |
| Shoulder dystocia | The incidence of shoulder dystocia | Delivery day |
| Hyperbilirubinemia | The incidence of hyperbilirubinemia requiring phototherapy or exchange transfusion | Hospital discharge (Day 2-3) |
| Transfusion of blood products or blood | The incidence of neonatal transfusion of blood products or blood | Hospital discharge (Day 2-3) |
| Hypoglycemia incidence | The incidence of hypoglycemia (blood glucose < 35mg/L) requiring intravenous treatment | Hospital discharge (Day 2-3) |
| Neonatal intensive care unit (NICU) admission | The incidence of admission to the NICU lasting more than 48 hours | Hospital discharge (Day 2-3) |
| Physical measurement indicators | Infant weight, length, head circumference, chest circumference, sitting height, upper arm circumference, subcutaneous fat, height-chest circumference index, crown-rump length/length | 6 weeks and 6 months |
| Growth balance indicators | 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 | 6 weeks and 6 months |
| Growth retardation | Height standard deviation for age < mean-2S or percentile method < P3 | 6 weeks and 6 months |
| Abnormal neurological examination | The proportion of abnormal results in neurological examinations (hearing development, nerve reflexes) | 6 weeks and 6 months |
| Scores of Bayley Scales of Infant and Toddler Development (Bayley-4) | Total score, cognitive scale score, language scale score, motor scale score, social-emotional scale score, adaptive behavior scale score | 6 weeks and 6 months |
| Scores of Ages & Stages Questionnaires®, Third Edition (ASQ-3) | Total score, communication domain score, gross motor domain score, fine motor domain score, problem-solving domain score, personal-social domain score | 6 weeks and 6 months |
| Incidence of allergic diseases | Allergic diseases diagnosed by neonatologists, including cow's milk allergy, allergic rhinitis, eczema/allergic dermatitis, asthma, wheezing and other allergic disorders | 6 weeks and 6 months |
| Time from randomization to delivery | Median time from randomization to birth of the fetus, measured in hours | Delivery day |
| Use of epidural analgesia | Rate of epidural analgesia use | Delivery day |
| Maternal length of hospital stays | Median maternal hospital stays, measured in hours | Hospital discharge (Day 2-3) |
| Neonatal length of hospital stays | Median neonatal hospital stays, measured in hours | Hospital discharge (Day 2-3) |
| Pre-insurance hospitalization cost | Total hospitalization cost during delivery, before insurance reimbursement | Hospital discharge (Day 2-3) |
| Out-of-pocket hospitalization cost | Out-of-pocket cost incurred during delivery hospitalization | Hospital discharge (Day 2-3) |
| Fecal metabolomic characteristics |
Non-targeted metabolomic macroscopic differences, core metabolomic differences (including tryptophan, fatty acids), and differences in gut microbiota metabolites |
| Meconium, first 48 hours, 7 days, 3 weeks, 6 weeks, 3 months, and 6 months |
| Cord blood metabolomic characteristics | Assessment of non-targeted metabolomic macroscopic differences and core metabolomic differences (including tryptophan, fatty acids) in cord blood plasma | Delivery day |
| Cord blood proteomic characteristics | Analysis of the proteomic characteristics of cord blood whole blood to trace back the health status during the fetal period | Delivery day |