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RecruitingNCT04964206

Neuraxial Labor Analgesia and Offspring Neurodevelopment

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
5,580 (estimated)
Sponsor
Dong-Xin Wang · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDURENeuraxial labor analgesiaEpidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.
PROCEDURENo neuraxial labor analgesiaNeuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.

Timeline

Start date
2022-10-14
Primary completion
2026-12-01
Completion
2028-12-01
First posted
2021-07-16
Last updated
2025-07-31

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT04964206. Inclusion in this directory is not an endorsement.