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NCT Number: NCT04964206

Neuraxial Labor Analgesia and Offspring Neurodevelopment

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Neuraxial labor analgesia

Procedure

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

No neuraxial labor analgesia

Procedure

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

Primary outcomes

  1. Prevalence of neurodevelopmental delay in offspring at 24 months of age

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Prevalence of maternal depressive symptoms

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-Xin Wang, MD,PHD

CONTACT

[email protected]

86-13910731903

Ting Ding, MD

CONTACT

[email protected]

86-13718803529

Sponsors and collaborators

Lead sponsor

Dong-Xin Wang

Other

Collaborators

  • Shenzhen Maternity & Child Healthcare Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Jul 16, 2021
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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