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Clinical Trials in China / NCT04964206
Recruiting Observational

Neuraxial Labor Analgesia and Offspring Neurodevelopment

NCT04964206 · tracked via the Priya Life Science China tracker
Sponsor
Dong-Xin Wang
Phase
Observational
Started
2022-10-14
Last updated
2026-06-09

Condition(s) studied

Pregnant WomenLabor PainAnalgesia, EpiduralInfantsNeurodevelopmental Disorders

Investigational drug(s) / intervention(s)

Neuraxial labor analgesiaNo neuraxial labor analgesia

Neuraxial labor analgesia: Epidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.

No neuraxial labor analgesia: Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.

Study summary

How perinatal factors affect the long-term development of children has always been an issue of much concern. This study is designed to explore the potential impact of maternal neuraxial labor analgesia exposure on offspring neurodevelopment.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
No
Inclusion Criteria: 1. Primiparae between 18 and 35 years of age with term single cephalic pregnancy; 2. Undergo regular prenatal examination in the study centers; 3. Preparing to deliver vaginally. Exclusion Criteria: 1. History of psychiatric diseases (indicate those that are diagnosed before or during pregnancy by psychiatrists); 2. History of diseases involving the hypothalamic-pituitary-adrenal axis; 3. Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy. 4. Presence of contraindications to vaginal delivery; 5. Other reasons that are considered unsuitable for study participation.

Primary outcome measure(s)

  • Prevalence of neurodevelopmental delay in offspring at 24 months of age — At 24 months of age
    Neurodevelopment will be assessed using the Ages \& Stages Questionnaires® in Chinese, 3rd edition (ASQ®-3 Chinese; suitable for children from 1 month to 60 months of age). The ASQ®-3 Chinese contains 30 items representing five developmental domains: communication, gross motor, fine motor, problem solving, and personal-social behavior. For each domain, a score that is more than 2 standard deviations below the mean indicates suspected neurodevelopmental delay. A score below the threshold in any of the 5 domains indicates suspected neurodevelopmental delay.

Trial sites (2)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting
Shenzhen Maternity and Child Healthcare Hospital Shenzhen Guangdong Recruiting

Other trials for the same condition

Exploring the Optimal Concentration of Lidocaine Test Dose for Labor Analgesia Active, not recruiting
Ningbo Maternity-Child Linked Database Study Active, not recruiting
Association of Gestational Cardiovascular Health With Pregnancy Outcomes Recruiting
Guangzhou Preterm and Term Birth Cohort Study Active, not recruiting
Motor Development Assessment and Support for Children With Neurodevelopmental Disorders Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04964206 on ClinicalTrials.gov ↗ ← All trials in China