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

Completed

• Conditions: Behavior; Neurodevelopmental Disorders
• Interventions: Other: Behavioural questionnaires and assessments on mother and child

• Registration Number: NCT05196750
• Lead Sponsor: National University Hospital, Singapore

Brief 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.

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 Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-10-24
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Status Verified: 2023-06
• Primary Completion: 2023-06-21
• Study Completion: 2023-06-21
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1176

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lower segment Caesarean section (LSCS)	Behavioural questionnaires and assessments on mother and child	Maternal delivery of delivery via lower segment Caesarean section (LSCS)
Normal vaginal delivery	Behavioural questionnaires and assessments on mother and child	Maternal delivery of delivery via normal vaginal delivery

Primary Outcome Measures

Name	Time	Method
Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes via questionnaires administered	Prenatal to postnatal up to 7 years	Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.
Association between Obstetric anesthesia events at delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered	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	Prenatal to postnatal up to 7 years	Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.

Trial Locations

Locations (2)

KKH Women and Children Hospital; 🇸🇬 Singapore, Singapore

National University Hospital; 🇸🇬 Singapore, Singapore