General Anaesthesia During PregnancyPAE-IQNCT06633406

Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia

An observational study of General Anaesthesia During Pregnancy, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Every year in the European Union, thousands of babies are exposed to anaesthesia before they are born because their mothers need surgery during pregnancy. While these surgeries are necessary, there is a concern that the anaesthesia might affect the baby's brain development. Read more about this study

Who is it for?: Ages 6 to 27 yearsHealthy volunteers can take part
Conditions the study is for: General Anaesthesia During Pregnancy
What is being tested?: Age-appropriate Wechsler Intelligence Test, Disruptive Behavior Disorders Rating Scale and Social Responsiveness Scale
Type of treatment: Injection or infusion
How many people: 192 participants
Where: 3 sitesBelgium
Study dates: 14 Oct 2024to Dec 2027
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 27 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: children from women who delivered in one of the participating hospitals

Who may be able to join

Prenatal anaesthesia exposure: Children exposed in utero to maternal general anaesthesia to allow laparoscopy or laparotomy for appendicectomy, adnexal pathology, cholecystectomy or for diagnostic procedures to rule out intra-abdominal pathology
No prenatal anaesthesia exposure: Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
Children exposed to inflammation: Children born to mothers diagnosed with inflammatory bowel disease (IBD) who had a flare-up during pregnancy without being exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero.
Children born in 2000-2023
(Parental) informed consent

Who cannot join

Children whose mothers underwent obstetric surgery or foetal surgery/interventions during the same pregnancy.
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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium3 sites

Imeldaziekenhuis
Bonheiden, Antwerpen, 2820
UZ Leuven
Leuven, Vlaams-Brabant, 3000
AZ Delta
Roeselare, West-Flanders, 8800

Other trials in Belgium

About this study

Official title: Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia for Maternal Abdominal Surgery: A Propensity Score Weighted Multicentre Clinical Bidirectional Cohort Study.

The goal of this cohort study is to compare the intelligence and neurodevelopmental outcome of children prenatally exposed to general anaesthesia for maternal abdominal surgery with those of unexposed children and with those of children prenatally exposed to maternal inflammation.

Conditions: General Anaesthesia During Pregnancy
Being tested: Age-appropriate Wechsler Intelligence Test, Disruptive Behavior Disorders Rating Scale, Social Responsiveness Scale
Keywords: anaesthesia, anaesthesia-induced neurotoxicity, pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Age-appropriate Wechsler Intelligence TestOther
6-16 years: Wechsler Intelligence Scale for Children (WISC V)
>17 years: Wechsler Adult Intelligence Scale (WAIS IV)
Disruptive Behavior Disorders Rating ScaleOther
Dutch version of the Disruptive Behavior Disorders Rating Scale
Social Responsiveness ScaleOther
6-18 years: social responsiveness scale 2 (SRS-2)
>19 years: Social Responsiveness Scale - Adult version (SRS-A)

Study groups in NCT06633406
Study group	Role	What they receive
Prenatal Anaesthesia Exposure		Children exposed in utero to maternal general anaesthesia to allow laparoscopy or laparotomy for appendicectomy, adnexal pathology, cholecystectomy or for diagnostic procedures to rule out intra-abdominal pathology Receives: Other: Age-appropriate Wechsler Intelligence Test; Other: Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale
No Prenatal Anaesthesia Exposure		Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero Receives: Other: Age-appropriate Wechsler Intelligence Test; Other: Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale
Prenatal exposure to maternal inflammation		Children prenatally exposed to maternal inflammation, specifically those born to mothers with inflammatory bowel disease (IBD) Receives: Other: Age-appropriate Wechsler Intelligence Test; Other: Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale

What is being measured

The primary outcome is the main question the study is designed to answer.

Wechsler full-scale intelligence quotient
Primary outcome will be the Wechsler full-scale intelligence quotient which will be assessed using the Wechsler Intelligence Scale for Children for children with an age of 7-16 years and the Wechsler Adult Intelligence Scale for children with an age of ≥ 17 years.
Measured: 1,5 hours (duration of intelligence testing and completion of questionnaires)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 2024Dec 2027

First posted9 Oct 2024
Study start14 Oct 2024
Primary completionOct 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for General Anaesthesia During PregnancyStudies of the same condition, open and under way.
More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 192 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06633406
Sponsor's protocol ID: S68647
Acronym: PAE-IQ
Status last verified: Jan 2026
First submitted: 20 Sep 2024
Last updated: 7 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingObservational study
A Longitudinal, Cohort Study Investigating the Impact of General Anaesthetic Caesarean Birth, With or Without ICU Admission, on Maternal Mental Health and Mother/Infant Bonding
General Anaesthesia During Pregnancy

All General Anaesthesia During Pregnancy trials