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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of labor epidural analgesia (LEA) on children's brain development when mothers use this method during childbirth. LEA is a common and effective way to relieve pain during labor, but some previous studies have suggested it might be linked to an increased risk of autism and other developmental issues in children. However, those studies had limitations, so this new research aims to provide clearer answers. The trial will compare siblings, one exposed to LEA during pregnancy and one not, to see if there are any differences in intelligence or development.

To be eligible for this study, children must be born between January 1, 2014, and November 1, 2019. One child must have been exposed to LEA during labor, while their sibling must not have been. The study will not include children with certain medical conditions or complications during pregnancy. Participants will undergo assessments to evaluate their cognitive abilities, helping to determine if LEA has any negative effects on children's development. This study hopes to reassure expectant mothers that using LEA for pain relief during labor is safe for their children's neurodevelopment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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