NCT04964206

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,645

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2022Dec 2028

First Submitted

Initial submission to the registry

July 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 14, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

4.1 years

First QC Date

July 6, 2021

Last Update Submit

June 5, 2026

Conditions

Labor PainInfantsPregnant WomenAnalgesia, EpiduralNeurodevelopmental Disorders

Keywords

Pregnant womenLabor painNeuraxial labour analgesiaInfantsNeurodevelopmental disorders

Outcome Measures

Primary Outcomes (1)

  • Prevalence of neurodevelopmental delay in offspring 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.

    At 24 months of age

Secondary Outcomes (2)

  • Prevalence of neurodevelopmental delay in offspring at 6 and 12 months of age

    At 6 and 12 months of age

  • Prevalence of maternal depressive symptoms

    At 42 days, 6 months, 12 months, and 24 months after childbirth

Study Arms (2)

Neuraxial analgesia exposure

For mothers who accept neuraxial labor analgesia, epidural analgesia or combined spinal-epidural analgesia will be provided according to routine practice of each study center.

Procedure: Neuraxial labor analgesia

No neuraxial analgesia exposure

For patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice.

Procedure: No neuraxial labor analgesia

Interventions

Neuraxial labor analgesiaPROCEDURE

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

Neuraxial analgesia exposure
No neuraxial labor analgesiaPROCEDURE

Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.

No neuraxial analgesia exposure

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Primiparae between 18 and 35 years of age with term single cephalic pregnancy who undergo regular prenatal examination in the study centers and are preparing to deliver vaginally.

You may qualify if:

  • Primiparae between 18 and 35 years of age with term single cephalic pregnancy;
  • Undergo regular prenatal examination in the study centers;
  • Preparing to deliver vaginally.

You may not qualify if:

  • History of psychiatric diseases (indicate those that are diagnosed before or during pregnancy by psychiatrists);
  • History of diseases involving the hypothalamic-pituitary-adrenal axis;
  • 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.
  • Presence of contraindications to vaginal delivery;
  • Other reasons that are considered unsuitable for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Shenzhen Maternity and Child Healthcare Hospital

Shenzhen, Guangdong, 518100, China

RECRUITING

Related Publications (6)

  • Liu ZH, He ST, Deng CM, Ding T, Xu MJ, Wang L, Li XY, Wang DX. Neuraxial labour analgesia is associated with a reduced risk of maternal depression at 2 years after childbirth: A multicentre, prospective, longitudinal study. Eur J Anaesthesiol. 2019 Oct;36(10):745-754. doi: 10.1097/EJA.0000000000001058.

    PMID: 31356375BACKGROUND

  • Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553.

    PMID: 21072284BACKGROUND

  • Morton S, Kua J, Mullington CJ. Epidural analgesia, intrapartum hyperthermia, and neonatal brain injury: a systematic review and meta-analysis. Br J Anaesth. 2021 Feb;126(2):500-515. doi: 10.1016/j.bja.2020.09.046. Epub 2020 Nov 18.

    PMID: 33218673BACKGROUND

  • Flick RP, Lee K, Hofer RE, Beinborn CW, Hambel EM, Klein MK, Gunn PW, Wilder RT, Katusic SK, Schroeder DR, Warner DO, Sprung J. Neuraxial labor analgesia for vaginal delivery and its effects on childhood learning disabilities. Anesth Analg. 2011 Jun;112(6):1424-31. doi: 10.1213/ANE.0b013e3181f2ecdd. Epub 2010 Aug 24.

    PMID: 20736436BACKGROUND

  • Wall-Wieler E, Bateman BT, Hanlon-Dearman A, Roos LL, Butwick AJ. Association of Epidural Labor Analgesia With Offspring Risk of Autism Spectrum Disorders. JAMA Pediatr. 2021 Jul 1;175(7):698-705. doi: 10.1001/jamapediatrics.2021.0376.

    PMID: 33871547BACKGROUND

  • Wei M, Bian X, Squires J, Yao G, Wang X, Xie H, Song W, Lu J, Zhu C, Yue H, Zhu G, Wang Q, Xu R, Wan C, Sun S, Chen J. [Studies of the norm and psychometrical properties of the ages and stages questionnaires, third edition, with a Chinese national sample]. Zhonghua Er Ke Za Zhi. 2015 Dec;53(12):913-8. Chinese.

    PMID: 26887546BACKGROUND

MeSH Terms

Conditions

Labor PainAgnosiaNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesMental Disorders

Study Officials

  • Dong-Xin Wang, MD,PHD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD,PHD

CONTACT

86-13910731903wangdongxin@hotmail.com

Ting Ding, MD

CONTACT

86-13718803529athenading01@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 16, 2021

Study Start

October 14, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)