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

NCT07014956 | Not Yet Recruiting

• 1 other identifier: S69530
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Epidural Analgesia, Obstetric

Keywords

Labour epidural analgesia; Neurodevelopmental outcome; Intelligence

Outcome Measures

Primary Outcomes (1)

• Wechsler full-scale intelligence quotient

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

  At te moment of neuropsychological testing

Secondary Outcomes (4)

• 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

Study Arms (2)

Exposed

Children prenatally exposed to labour epidural analgesia

Procedure: Labour epidural analgesia

Unexposed

Prenatally not exposed to labour epidural analgesia

Interventions

Labour epidural analgesia PROCEDURE

Prenatal exposure to labour epidural analgesia during delivery

Exposed

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Sibling pairs discordant for prenatal exposure to labour epidural analgesia will be included

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Central Study Contacts

Tom Bleeser, MD, PhD

CONTACT

+3216344270; tom.bleeser@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 11, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Can be requested from authors.
• Access Criteria: Can be requested from authors.

Locations

BE (1)