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

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.

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Key information

Conditions

Neurodevelopmental Disorders Behavior Mental Disorders

Age range

0 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KKH Women and Children Hospital, Singapore

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioural questionnaires and assessments on mother and child

Other

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

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jan 19, 2022
Registry last updated: Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed