RecruitingNCT04964206

Neuraxial Labor Analgesia and Offspring Neurodevelopment

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


Sponsor

Dong-Xin Wang

Enrollment

5,580 participants

Start Date

Oct 14, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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.

Interventions

PROCEDURENeuraxial labor analgesia

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

PROCEDURENo neuraxial labor analgesia

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


Locations(2)

Peking University First Hospital

Beijing, Beijing Municipality, China

Shenzhen Maternity and Child Healthcare Hospital

Shenzhen, Guangdong, China

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NCT04964206


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