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临床试验/NCT07014956
NCT07014956尚未招募不适用

Intelligence and Neurodevelopmental Outcome After Prenatal Exposure to Labour Epidural Analgesia: a Sibling Matched Clinical Ambidirectional Cohort Study

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
128
试验地点
1
主要终点
Wechsler full-scale intelligence quotient

研究概览

简要总结

In Belgium, labour epidural analgesia (LEA) has been used for decades in the vast majority of vaginal deliveries (up to 83% of deliveries). Labour epidural analgesia is the most effective and safest way to allow pregnant women a nearly pain-free labour- and birth experience. Recent data showed that the use of LEA was associated with a reduced risk for severe maternal morbidity, neonatal resuscitation and with a reduced risk for low Apgar scores. However, prenatal exposure to labour epidural analgesia has been associated by several study groups with an increased risk for autism spectrum disorder (ASD) in the children, but these studies suffer from several important limitations which may have induced significant bias (e.g., not correcting for unmeasured confounders). Associations with other neurodevelopmental disorders (e.g., Attention Deficit Hyperactivity Disorder (ADHD), oppositional defiant disorder (ODD) and conduct disorder (CD)) and cognitive functioning have not been investigated yet. There is hence an urgent need for a study allowing definitive conclusions by overcoming the limitations of the previous studies. The investigators will perform the first sibling-matched clinical cohort study using a prospective investigator-assessment of multiple domains of cognitive functions. The investigators hypothesize that prenatal exposure to LEA will neither be associated with reduced intelligence nor with more neurodevelopmental disorders. Validating this hypothesis holds the potential to grant women the assurance to confidently receive the most efficacious method for labour analgesia, free from apprehension that it might have adverse implications for their children's neurodevelopment.

详细描述

Primary objective:

To compare the intelligence of children prenatally exposed to labour epidural analgesia with that of sibling matched unexposed children.

Secondary objective(s):

To compare parentally reported traits of ASD, ADHD, ODD and CD of children prenatally exposed to labour epidural analgesia with that of sibling matched unexposed children.

Endpoints:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Exposed children: Children prenatally exposed to labour epidural analgesia
  • •Unexposed children: Sibling of an exposed child, Prenatally not exposed to labour epidural analgesia
  • •Exposed & unexposed children: Children born from 1st January 2014 until 1st November 2019, Parental informed consent

排除标准

  • •Children whose mothers underwent maternal surgery or foetal surgery/interventions during the same pregnancy.
  • •Children exposed to general anaesthesia after birth
  • •Children prenatally exposed to chemotherapy, radiotherapy, radiology, oncologic pathology
  • •Children born at a gestational age < 37 weeks or > 42 weeks, or with a birth weight < 2.5 kg
  • •Twins, triplets, multiple births
  • •No Dutch-speaking children
  • •Diagnosis of severe disability of genetic origin (e.g., Fragil X, Down syndrome,...), history of head trauma, major congenital birth defects
  • •Elective caesarean section and intrapartum caesarean section (the number of caesarean sections will be reported and compared between both groups)
  • •Foetus died before start of delivery

结局指标

主要结局

Wechsler full-scale intelligence quotient

时间窗: At te moment of neuropsychological testing

Will be assessed using the Wechsler Intelligence Scale for Children (WISC). Minimum value: 40, maximum value: 160. Higher scores mean a better outcome.

次要结局

  • Indices of the Wechsler intelligence scale(At te moment of neuropsychological testing)
  • Clinically relevantly decreased intelligence quotient(At te moment of neuropsychological testing)
  • Social responsiveness scale (SRS)(At te moment of neuropsychological testing)
  • Disruptive Behavior Disorders Rating Scale (DBDRS)(At te moment of neuropsychological testing)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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