Neuraxial Labor Analgesia and Offspring Neurodevelopment
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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 2 years of age.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Neuraxial analgesia exposure 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. |
Procedure: Neuraxial labor analgesia
Epidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.
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| No neuraxial analgesia exposure For patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice. |
Procedure: No neuraxial labor analgesia
Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.
|
Outcome Measures
Primary Outcome Measures
- Incidence of developmental delay in offspring [At 2 years of age]
Developmental screening is performed with the Chinese version Ages and Stages Questionnaires-Third Edition (ASQ-C). The ASQ-C contains five major developmental domains (communication, gross motor, fine motor, problem solving and personal-social skills); each domain consists six questions. The score on each of the six questions is summed to obtain an ASQ-C domain score. The score on each domain is summed to obtain an ASQ-C total score. A total score of less than two standard deviations from the mean of the Chinese reference group is considered as developmental delay.
Secondary Outcome Measures
- Pain intensity during labor [Up to the end of childbirth (end of stage 3)]
Pain intensity during labor is assessed using a numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain. Pain intensity is assessed every 1-3 hours by the bedside nurse. PIP = ([baseline pain score - average intrapartum pain score]/baseline pain score) × 100
- Maternal fever during labor [Up to the end of childbirth (end of stage 3)]
Defined as the highest maternal temperature ≥38.0℃ during any stage of labor
- Maternal satisfaction with the experience of childbirth [At 24 hours postpartum]
Women are asked to rate their satisfaction with the experience of childbirth by answering "I am satisfied with the overall experience of delivery" using a 5-point scale (strongly agree, agree, neutral, disagree, and strongly disagree).
- Neonatal adverse events [Up to 24 hours postpartum]
Indicate any event that lead to admission to the neonatal intensive care unit or neonatal ward, including fetal distress/asphyxia, aspiration pneumonia, premature birth/low-birth weight, glucopenia, jaundice/hyperbilirubinemia, infection, convulsion and anal atresia.
- Status of neonatal feeding [At 24 hours and 42 days postpartum]
The mode of neonatal feeding include breast feeding, mixed feeding, and formula feeding.
- Pain intensity after childbirth [At 24 hours and 42 days postpartum]
Intensity of pain is evaluated with the Numeric Rating Scale (NRS), an 11-point scale where 0 indicates no pain and 10 the most severe pain.
- New-onset diseases in mothers [Up to 2 years after childbirth]
Indicate any new-onset diseases or aggravation of original disease that requires therapy.
- New-onset disease in children [Up to 2 years of age]
Indicate any congenital (e.g., atrial septal defect, anal atresia and urachal fistula) and acquired diseases (e.g., bronchiolitis, febrile convulsion, Kawasaki disease, infant rash, eczema, urticaria, allergic dermatitis, pneumonia, anemia, inguinal hernia and enteritis) that requires therapy.
- Depression score in mothers [At 42 days, 1 year, and 2 years after childbirth]
Maternal depression is assessed with the Edinburgh Postnatal Depression Scale. A score of 10 or higher is defined the presence of depression.
- Persistent pain in mothers [At 1 year and 2 years after childbirth]
Persistent pain is defined as new-onset or aggravated pain that persist for 3 months or longer after childbirth. Persistent pain affecting life indicates one of the following activities (including walking, mood, sleep or concentration) is affected by persistent pain, as judged by parturients themselves.
- Quality of life in mothers [At 1 year and 2 years after childbirth]
Quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF; a 24-item questionnaire that assesses the quality of life in physical, psychological, social relationship and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function).
- Body weight in offspring [At 1 year and 2 years of age]
Evaluated according to "Reference standard for growth and development of children under 7 years old in China"
- Body height in offspring [At 1 year and 2 years of age]
Evaluated according to "Reference standard for growth and development of children under 7 years old in China"
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primiparae between 18 and 34 years of age with term single cephalic pregnancy;
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Undergo regular prenatal examination in the study centers;
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Preparing to deliver vaginally.
Exclusion Criteria:
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History of psychiatric diseases (indicate those that are diagnosed before or during pregnancy by psychiatrists);
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History of diseases involving the hypothalamic-pituitary-adrenal axis;
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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.
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Presence of contraindications to vaginal delivery;
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Other reasons that are considered unsuitable for study participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong | China | |
| 2 | Beijing Gynecological and obstetrical hospital | Beijing | China | ||
| 3 | Peking Union Medical Collage Hospital | Beijing | China | ||
| 4 | Peking University People's Hospital | Beijing | China |
Sponsors and Collaborators
- Dong-Xin Wang
- Peking University People's Hospital
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Dong-Xin Wang, MD,PHD, Peking University First Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54.
- 2021-026