Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-02 @ 8:40 AM
Study NCT ID:
NCT05196750
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2021-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Obstetric Anesthesia and Delivery Mode On Neurodevelopmental And Behavioural Outcomes In A Population-Based Birth Cohort
Sponsor:
National University Hospital, Singapore
Organization:
Study Overview
Official Title:
Effect of Obstetric Anesthesia and Delivery Mode On Neurodevelopmental And Behavioural Outcomes In A Population-Based Birth Cohort
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: