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

July 24, 2023 updated by: National University Hospital, Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore
        • KKH Women and Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

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.

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal vaginal delivery
Maternal delivery of delivery via normal vaginal delivery
Other: Behavioural 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
Lower segment Caesarean section (LSCS)
Maternal delivery of delivery via lower segment Caesarean section (LSCS)
Other: Behavioural 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Obstetric anesthesia events at delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered
Time Frame: Prenatal to postnatal up to 7 years
To establish an association with the prenatal, antenatal and postnatal data previously collected in the GUSTO study.
Prenatal to postnatal up to 7 years
Mode of delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered
Time Frame: Prenatal to postnatal up to 7 years
Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.
Prenatal to postnatal up to 7 years
Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes via questionnaires administered
Time Frame: Prenatal to postnatal up to 7 years
Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.
Prenatal to postnatal up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Choon Looi Bong, KKH Women and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

June 21, 2023

Study Completion (Actual)

June 21, 2023

Study Registration Dates

First Submitted

October 24, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB 2021/2113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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