Neuraxial Labor Analgesia and Offspring Neurodevelopment
ID: NCT04964206
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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.
Read Full Scientific Objectives & Methods
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.
Epidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.
Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.
Treatment Arms 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.
For patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice.
- 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.
- 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.
Primary Outcome Measures
- Prevalence of neurodevelopmental delay in offspring at 24 months of age — Time Frame: At 24 months of age
Neurodevelopment will be assessed using the Ages \& Stages Questionnaires® in Chinese, 3rd edition (ASQ®-3 Chinese; suitable for children from 1 month to 60 months of age). The ASQ®-3 Chinese contains 30 items representing five developmental domains: communication, gross motor, fine motor, problem solving, and personal-social behavior. For each domain, a score that is more than 2 standard deviations below the mean indicates suspected neurodevelopmental delay. A score below the threshold in any of the 5 domains indicates suspected neurodevelopmental delay.
View Secondary Outcome Measures (2)
- Prevalence of neurodevelopmental delay in offspring at 6 and 12 months of age — Time Frame: At 6 and 12 months of age
Neurodevelopment will be assessed using the Ages \& Stages Questionnaires® in Chinese, 3rd edition (ASQ®-3 Chinese; suitable for children from 1 month to 60 months of age). The ASQ®-3 Chinese contains 30 items representing five developmental domains: communication, gross motor, fine motor, problem solving, and personal-social behavior. For each domain, a score that is more than 2 standard deviations below the mean indicates suspected developmental delay. A score below the threshold in any of the 5 domains indicates suspected developmental delay.
- Prevalence of maternal depressive symptoms — Time Frame: At 42 days, 6 months, 12 months, and 24 months after childbirth
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; scores range from 0 to 30, with higher scores inddicating more severe depressive symptoms). A EPDS score of 10 or higher is defined the presence of depressive symptoms.
This trial is recruiting at 2 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 2 Facilities & Contact Sites
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- 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.PubMed ↗
- Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553.PubMed ↗
- 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.PubMed ↗
- 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.PubMed ↗
- 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.PubMed ↗
View Official Medical/Scientific Title
Impact of Maternal Neuraxial Labor Analgesia on Offspring Neurodevelopment. A Multicenter, Prospective, Longitudinal Cohort Study