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Pregnant WomenNCT04964206

Neuraxial Labor Analgesia and Offspring Neurodevelopment

An observational study of Pregnant Women and Labor Pain, run by Dong-Xin Wang at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Pregnant Women, Labor Pain, Analgesia, Epidural
What is being tested?
Neuraxial labor analgesia and No neuraxial labor analgesia
Type of treatment
Surgery or procedure
How many people
4,645 participants
Where
2 sitesChina
Study dates
14 Oct 2022to Dec 2028
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dong-Xin Wang, MD,PHD contact

86-13910731903

wangdongxin@hotmail.com

Ting Ding, MD contact

86-13718803529

athenading01@hotmail.com

China2 sites, 2 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Dong-Xin Wang, MD, PHD, +8610-83572784, wangdongxin@hotmail.com

    Ting Ding, MD, 13718803529, athena_d@sina.com

    Recruiting

  • Shenzhen Maternity and Child Healthcare Hospital

    Shenzhen, Guangdong, 518100

    Yuantao Li, MD

    Recruiting

Other trials in China

About this study

Official title: Impact of Maternal Neuraxial Labor Analgesia on Offspring Neurodevelopment. A Multicenter, Prospective, Longitudinal Cohort Study

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.

Read the detailed description

Neuraxial labor analgesia, including epidural analgesia and combined spinal-epidural analgesia, is a well-established technique to alleviate labor pain. It can help to reduce the maternal stress response during labor and might be associated with a lower risk of maternal postpartum depression; which may be beneficial to the long-term neurodevelopment in offspring.

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.

Being tested
Neuraxial labor analgesia, No neuraxial labor analgesia
Keywords
Pregnant women, Labor pain, Neuraxial labour analgesia, Infants, Neurodevelopmental disorders
Medical subject headings
Labor Pain, Agnosia, Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuraxial labor analgesiaProcedure or surgery

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

  • No neuraxial labor analgesiaProcedure or surgery

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

Study groups in NCT04964206
Study groupRoleWhat they receive
Neuraxial analgesia exposureFor mothers who accept neuraxial labor analgesia, epidural analgesia or combined spinal-epidural analgesia will be provided according to routine practice of each study center.
Receives: Procedure: Neuraxial labor analgesia
No neuraxial analgesia exposureFor patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice.
Receives: Procedure: No neuraxial labor analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 24 months of age

Secondary outcomes (2)

  1. Prevalence of neurodevelopmental delay in offspring at 6 and 12 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 developmental delay. A score below the threshold in any of the 5 domains indicates suspected developmental delay.

    Measured: At 6 and 12 months of age

  2. Prevalence of maternal depressive symptoms

    Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; scores range from 0 to 30, with higher scores inddicating more severe depressive symptoms). A EPDS score of 10 or higher is defined the presence of depressive symptoms.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start14 Oct 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,645 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04964206
Sponsor's protocol ID
2021-026
Status last verified
Jun 2026
First submitted
6 Jul 2021
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31356375

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

    PubMed 21072284

  • 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.

    PubMed 33218673

  • 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.

    PubMed 20736436

  • 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.

    PubMed 33871547

  • 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.

    PubMed 26887546

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnant Women and Labor Pain, run by Dong-Xin Wang at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong-Xin Wang, MD,PHD (86-13910731903, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of neurodevelopmental delay in offspring at 24 months of age (time frame: At 24 months of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04964206, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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