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CompletedNCT05196750Updated Jul 27, 2023

Effect of Obstetric Anesthesia and Delivery Mode On Neurodevelopmental And Behavioural Outcomes In A Population-Based Birth Cohort

An observational study in Neurodevelopmental Disorders and Behavior, sponsored by National University Hospital, Singapore. Completed at 2 sites in Singapore. Open to participants aged 0 Years to 10 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by National University Hospital, Singapore · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,176
Ages
0 Years to 10 Years
Sex
All
01

Study summary

The study aims to determine:

  1. The association between Obstetric anesthesia events at delivery (such as mode of anesthesia, drugs given, desaturation and hypotension) on pediatric neurodevelopmental and behavioural outcomes.
  2. Mode of delivery on pediatric neurodevelopmental and behavioural outcomes.
  3. Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes.
  4. To determine if these would differ between very preterm, moderate preterm, late preterm and term infants.

The study team hypothesise that:

  1. Adverse maternal events during anesthesia and labor analgesia may be associated with poorer neurodevelopmental outcomes in infants.
  2. Delivery via a lower segment caesarean section (LSCS) combined with a general anesthetic during delivery may be associated with adverse pediatric neurodevelopmental and behavioural outcomes.
  3. The use of labour epidural analgesia is associated with poorer neurodevelopmental and behavioural outcomes.
  4. These differences may be more pronounced in preterm infants as compared to term infants.
Read the detailed description

The relationship between the mode of delivery, type of anesthesia received, maternal anesthetic events at delivery and its effects on pediatric neurodevelopment and behavioral outcomes remains poorly defined with previous work showing conflicting results. Furthermore, previous studies have failed to take into account the potential effect of other antepartum anesthetic events such as the type of anesthesia, hypotension or desaturation. Furthermore, majority have failed to stratify between the subsets of premature infants, who may inherently be more susceptible to neurodevelopmental insult.

The GUSTO study is well-placed to provide unique insight with regards to these domains, due to its comprehensive, sensitive and specific follow-up of pediatric neurocognitive development and in-depth maternal anesthetic delivery data. Hence, previously collected, existing data from the Growing Up in Singapore Towards healthy Outcomes (GUSTO) cohort study will be utilized for this study.

This will be supplemented by additional maternal anesthetic and delivery data which the investigators aim to collect via a retrospective chart review.

02

Conditions studied

  • Neurodevelopmental Disorders
  • Behavior

Keywords

  • Obstetric Anaesthesia
03

In context

Neurodevelopmental Disorders

332 studies on the registry are indexed under Neurodevelopmental Disorders; 143 are open to participants now.

This study's enrollment of 1,176 is above the median of 200 across 124 observational studies indexed under Neurodevelopmental Disorders.

Browse Neurodevelopmental Disorders studies →

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 10 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All mothers and infants recruited into the GUSTO database from 2011 to 2016, who underwent neurodevelopmental follow-ups.

Inclusion criteria

  • All mothers and infants recruited into the GUSTO database from 2011 to 2016, who underwent neurodevelopmental follow-up will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • Children who dropped out of the study before 18 months of age
  • Children who had subsequent exposure to general anaesthesia/surgeries/sedatives
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,176 participants (actual)
Patient registry
No

Groups and cohorts

  • Normal vaginal delivery

    Maternal delivery of delivery via normal vaginal delivery

    Other: Behavioural questionnaires and assessments on mother and child

  • Lower segment Caesarean section (LSCS)

    Maternal delivery of delivery via lower segment Caesarean section (LSCS)

    Other: Behavioural questionnaires and assessments on mother and child

Interventions

  • OtherBehavioural questionnaires and assessments on mother and child

    Questionnaires include, but not limited to, State Trait Anxiety Inventory, Beck Depression Inventory, LYNDON Maternal Health and Well Being, Facial Imitation Task, Deferred Imitation, Habituation, Relational Binding, Behavioural Observation, Mirror Self Recognition, Standardized Assessment and Experimental Task, Snack and Sticker Delay, Implicit Attitude Test

06

What researchers measure

Primary outcomes

  1. Association between Obstetric anesthesia events at delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered

    To establish an association with the prenatal, antenatal and postnatal data previously collected in the GUSTO study.

    Time frame: Prenatal to postnatal up to 7 years

  2. Mode of delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered

    Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.

    Time frame: Prenatal to postnatal up to 7 years

  3. Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes via questionnaires administered

    Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.

    Time frame: Prenatal to postnatal up to 7 years

07

Study locations

2 sites
  • National University Hospital
    Singapore, 119074, Singapore
  • KKH Women and Children Hospital
    Singapore, Singapore
08

References and documents

Publications

  • Sprung J, Flick RP, Wilder RT, Katusic SK, Pike TL, Dingli M, Gleich SJ, Schroeder DR, Barbaresi WJ, Hanson AC, Warner DO. Anesthesia for cesarean delivery and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Aug;111(2):302-10. doi: 10.1097/ALN.0b013e3181adf481. PubMed 19602960 ↗
  • Chen G, Chiang WL, Shu BC, Guo YL, Chiou ST, Chiang TL. Associations of caesarean delivery and the occurrence of neurodevelopmental disorders, asthma or obesity in childhood based on Taiwan birth cohort study. BMJ Open. 2017 Sep 27;7(9):e017086. doi: 10.1136/bmjopen-2017-017086. PubMed 28963295 ↗
  • Curran EA, O'Neill SM, Cryan JF, Kenny LC, Dinan TG, Khashan AS, Kearney PM. Research review: Birth by caesarean section and development of autism spectrum disorder and attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. J Child Psychol Psychiatry. 2015 May;56(5):500-8. doi: 10.1111/jcpp.12351. Epub 2014 Oct 27. PubMed 25348074 ↗
  • Qiu C, Lin JC, Shi JM, Chow T, Desai VN, Nguyen VT, Riewerts RJ, Feldman RK, Segal S, Xiang AH. Association Between Epidural Analgesia During Labor and Risk of Autism Spectrum Disorders in Offspring. JAMA Pediatr. 2020 Dec 1;174(12):1168-1175. doi: 10.1001/jamapediatrics.2020.3231. PubMed 33044486 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05196750
Lead sponsor
National University Hospital, Singapore
Responsible party
Sponsor
First posted
Jan 19, 2022
Start date
Aug 1, 2021
Primary completion
Jun 21, 2023
Completion
Jun 21, 2023
Last update
Jul 27, 2023

Study contacts

Choon Looi Bong
principal investigator · KKH Women and Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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