Neuraxial Labor Analgesia and Offspring Neurodevelopment

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Neuraxial labor analgesia
  Epidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.
• Процедура No neuraxial labor analgesia
  Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.

Первичные конечные точки

• Prevalence of neurodevelopmental delay in offspring at 24 months of age [Срок оценки: At 24 months of age]

Вторичные конечные точки (2)

• Prevalence of neurodevelopmental delay in offspring at 6 and 12 months of age [Срок оценки: At 6 and 12 months of age]
• Prevalence of maternal depressive symptoms [Срок оценки: At 42 days, 6 months, 12 months, and 24 months after childbirth]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Peking University First Hospital — Пекин
• Shenzhen Maternity and Child Healthcare Hospital — Шэньчжэнь

Публикации

• Liu ZH, He ST, Deng CM, Ding T, Xu MJ, Wang L, Li XY, Wang DX. Neuraxial labour analgesia is associated with a reduced risk of maternal depression at 2 years after childbirth: A multicentre, prospective, longitudinal study. Eur J Anaesthesiol. 2019 Oct;36(10):745-754. doi: 10.1097/EJA.0000000000001058. PMID 31356375
• Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553. PMID 21072284
• Morton S, Kua J, Mullington CJ. Epidural analgesia, intrapartum hyperthermia, and neonatal brain injury: a systematic review and meta-analysis. Br J Anaesth. 2021 Feb;126(2):500-515. doi: 10.1016/j.bja.2020.09.046. Epub 2020 Nov 18. PMID 33218673
• Flick RP, Lee K, Hofer RE, Beinborn CW, Hambel EM, Klein MK, Gunn PW, Wilder RT, Katusic SK, Schroeder DR, Warner DO, Sprung J. Neuraxial labor analgesia for vaginal delivery and its effects on childhood learning disabilities. Anesth Analg. 2011 Jun;112(6):1424-31. doi: 10.1213/ANE.0b013e3181f2ecdd. Epub 2010 Aug 24. PMID 20736436
• Wall-Wieler E, Bateman BT, Hanlon-Dearman A, Roos LL, Butwick AJ. Association of Epidural Labor Analgesia With Offspring Risk of Autism Spectrum Disorders. JAMA Pediatr. 2021 Jul 1;175(7):698-705. doi: 10.1001/jamapediatrics.2021.0376. PMID 33871547
• Wei M, Bian X, Squires J, Yao G, Wang X, Xie H, Song W, Lu J, Zhu C, Yue H, Zhu G, Wang Q, Xu R, Wan C, Sun S, Chen J. [Studies of the norm and psychometrical properties of the ages and stages questionnaires, third edition, with a Chinese national sample]. Zhonghua Er Ke Za Zhi. 2015 Dec;53(12):913-8. Chinese. PMID 26887546

Идентификаторы

NCT: NCT04964206 · 2021-026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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