Neuraxial Labor Analgesia and Offspring Neurodevelopment

NCT04964206 | Recruiting DMC

• 1 other identifier: 2021-026
• Study Type: observational
• Target: 5,580
• Locations: 1 country
• Sites: 2

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.

Conditions

Offspring, Adult; Labor Pain; Maternal Anesthesia and Analgesia Affecting Fetus or Newborn; Neurodevelopmental Delay; Postpartum Depression

Keywords

Neuraxial labour analgesia; Neurodevelopmental delay

Outcome Measures

Primary Outcomes (1)

• Incidence of developmental delay in offspring at 24 months of age

  The Ages \& Stages Questionnaires® in Chinese, 3rd edition (ASQ®-3 Chinese) will be used to detect developmental delays among 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 developmental delay. A score below the threshold in any of the 5 domains indicates suspected developmental delay.

  At 24 months of age

Secondary Outcomes (6)

• Incidence of developmental delay in offspring at 6 and 12 months of age

  At 6 and 12 months of age

• Maternal intrapartum fever

  Up to the end of childbirth (stage 3)

• Neonatal Apgar score <8 at 1 and 5 minutes after delivery

  At 1 and 5 minutes after delivery

• Histologic chorioamnionitis

  Up to hospital discharge

• Neonatal infection

  Within 3 days after birth

Other Outcomes (6)

• Use of oxytocin

  Up to the end of childbirth (stage 3)

• Maternal use of antibiotics

  Up to hospital discharge

• Neonatal admission to the neonatal intensive care unit

  Up to hospital discharge

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 analgesia PROCEDURE

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 analgesia PROCEDURE

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

No neuraxial analgesia exposure

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-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.

Sponsors & Collaborators

• Dong-Xin Wang: lead
• Shenzhen Maternity and Child Healthcare Hospital: collaborator

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: 31356375 BACKGROUND

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

  PMID: 21072284 BACKGROUND

• 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: 33218673 BACKGROUND

• 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: 20736436 BACKGROUND

• 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: 33871547 BACKGROUND

• 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: 26887546 BACKGROUND

MeSH Terms

Conditions

Labor Pain; Depression, Postpartum

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Dong-Xin Wang, MD,PHD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD,PHD

CONTACT

86-13910731903; wangdongxin@hotmail.com

Ting Ding, MD

CONTACT

86-13718803529; athenading01@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: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)