Impact of Labor Pain Relief on Child Development

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

This study looks at whether using epidurals for pain relief during labor affects how children develop by the time they are two years old.

Quick facts

• Study type: Observational
• Enrollment: 5580 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Female
• Sponsor: Peking University First Hospital (other)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT04964206 on ClinicalTrials.gov

What this trial studies

This observational study investigates how maternal exposure to neuraxial labor analgesia, such as epidurals, affects the long-term neurodevelopment of children. It aims to determine if there is a correlation between the use of this pain relief method during labor and the risk of neurodevelopmental delays in offspring at 24 months of age. The study will compare outcomes between mothers who receive neuraxial analgesia and those who do not, while considering various maternal and neonatal health factors.

Who should consider this trial

Good fit: Ideal candidates are first-time mothers aged 18 to 35 with a term single cephalic pregnancy planning for vaginal delivery.

Not a fit: Patients with a history of psychiatric diseases or contraindications to epidural analgesia or vaginal delivery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safest pain management options during labor that promote optimal neurodevelopment in children.

How similar studies have performed: While there have been studies on labor analgesia and maternal outcomes, the specific focus on long-term neurodevelopmental effects in offspring remains an area of ongoing investigation.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Peking University First Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Shenzhen Maternity and Child Healthcare Hospital — Shenzhen, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Dong-Xin Wang, MD,PHD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD,PHD

Conditions: Offspring, Adult, Labor Pain, Maternal Anesthesia and Analgesia Affecting Fetus or Newborn, Neurodevelopmental Delay, Postpartum Depression, Neuraxial labour analgesia, Neurodevelopmental delay