Neuraxial Labor Analgesia and Offspring Neurodevelopment
NCT ID: NCT04964206
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5580 participants
OBSERVATIONAL
2022-10-14
2028-12-31
Brief Summary
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Detailed Description
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On the other hand, neuraxial labor analgesia is associated with increased risks of intrapartum maternal fever and instrumental delivery, which may produce potentially harmful effects. In addition, it has been reported that the anesthetic exposure during neuraxial analgesia may lead to fetal-neonatal depression and even neurotoxic effects of less mature neonatal brain. Taking all these into account, the potential long-term effects of neuraxial analgesia on offspring neurodevelopment is still controversial and deserves further study.
The objective of study is to investigate if there is any association between maternal neuraxial analgesia exposure during labor and risk of offspring neurodevelopment delay at age 24 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Neuraxial labor analgesia
Epidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.
No neuraxial analgesia exposure
For patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice.
No neuraxial labor analgesia
Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Undergo regular prenatal examination in the study centers;
3. Preparing to deliver vaginally.
Exclusion Criteria
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.
18 Years
35 Years
FEMALE
No
Sponsors
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Shenzhen Maternity and Child Healthcare Hospital
UNKNOWN
Dong-Xin Wang
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Principal Investigators
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Dong-Xin Wang, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Shenzhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Yuantao Li, MD
Role: primary
References
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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.
Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553.
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.
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.
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.
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.
Other Identifiers
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2021-026
Identifier Type: -
Identifier Source: org_study_id
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