Trials / Recruiting
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
- Offspring, Adult
- Labor Pain
- Maternal Anesthesia and Analgesia Affecting Fetus or Newborn
- Neurodevelopmental Delay
- Postpartum Depression
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Neuraxial labor analgesia | Epidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center. |
| PROCEDURE | No neuraxial labor analgesia | Neuraxial 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.