Neuraxial Labor Analgesia and Offspring Neurodevelopment

Dong-Xin Wang

Status: Enrolling

Conditions: Labor Pain; Neurodevelopmental Delay; Maternal Anesthesia and Analgesia Affecting Fetus or Newborn; Offspring, Adult; Postpartum Depression

Treatments: Procedure: Neuraxial labor analgesia; Procedure: No neuraxial labor analgesia

Study type: Observational

Funder types: Other

Identifiers

NCT04964206

2021-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,580 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Primiparae between 18 and 35 years of age with term single cephalic pregnancy;
2. Undergo regular prenatal examination in the study centers;
3. Preparing to deliver vaginally.

Exclusion criteria

1. History of psychiatric diseases (indicate those that are diagnosed before or during pregnancy by psychiatrists);
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.

Trial design

5,580 participants in 2 patient groups

Neuraxial analgesia exposure

Description:

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.

Treatment:

Procedure: Neuraxial labor analgesia

No neuraxial analgesia exposure

Description:

For patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice.

Treatment:

Procedure: No neuraxial labor analgesia