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.
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
- Are there results?
- Not yet: the study is under way
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
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.
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. However, there isn't enough research to know for sure how this exposure might impact the child's intelligence or behavior later in life.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Devroe, MD, Phd, Principal investigator, UZ Leuven
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06633406
- Acronym / sponsor ID
- PAE-IQ / S68647
- Conditions
- General Anaesthesia During Pregnancy
- Keywords
- anaesthesia, anaesthesia-induced neurotoxicity, pregnancy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. However, there isn't enough research to know for sure how this exposure might impact the child's intelligence or behavior later in life.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prenatal Anaesthesia Exposure | – | Other: Age-appropriate Wechsler Intelligence Test, Other: Disruptive Behavior Disorders Rating Scale, Other: Social Responsiveness ScaleChildren 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 | – | Other: Age-appropriate Wechsler Intelligence Test, Other: Disruptive Behavior Disorders Rating Scale, Other: Social Responsiveness ScaleChildren not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero |
| Prenatal exposure to maternal inflammation | – | Other: Age-appropriate Wechsler Intelligence Test, Other: Disruptive Behavior Disorders Rating Scale, Other: Social Responsiveness ScaleChildren prenatally exposed to maternal inflammation, specifically those born to mothers with inflammatory bowel disease (IBD) |
Who may qualify
- Ages
- 6 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children from women who delivered in one of the participating hospitals
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Age-appropriate Wechsler Intelligence Test6-16 years: Wechsler Intelligence Scale for Children (WISC V) >17 years: Wechsler Adult Intelligence Scale (WAIS IV) | Other | No Prenatal Anaesthesia Exposure, Prenatal Anaesthesia Exposure, Prenatal exposure to maternal inflammation |
| Disruptive Behavior Disorders Rating ScaleDutch version of the Disruptive Behavior Disorders Rating Scale | Other | No Prenatal Anaesthesia Exposure, Prenatal Anaesthesia Exposure, Prenatal exposure to maternal inflammation |
| Social Responsiveness Scale6-18 years: social responsiveness scale 2 (SRS-2) >19 years: Social Responsiveness Scale - Adult version (SRS-A) | Other | No Prenatal Anaesthesia Exposure, Prenatal Anaesthesia Exposure, Prenatal exposure to maternal inflammation |
Primary outcome
Wechsler full-scale intelligence quotient
Time frame: 1,5 hours (duration of intelligence testing and completion of questionnaires)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Devroe, MD, Phd principal investigator
UZ Leuven
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anaesthesia During Pregnancy, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler full-scale intelligence quotient (time frame: 1,5 hours (duration of intelligence testing and completion of questionnaires)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.