Trials / Completed
CompletedNCT05196750
Effect of Obstetric Anesthesia and Delivery Mode On Neurodevelopmental And Behavioural Outcomes In A Population-Based Birth Cohort
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,176 (actual)
- Sponsor
- National University Hospital, Singapore · Academic / Other
- Sex
- All
- Age
- 0 Years – 10 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2023-06-21
- Completion
- 2023-06-21
- First posted
- 2022-01-19
- Last updated
- 2023-07-27
Locations
2 sites across 1 country: Singapore
Source: ClinicalTrials.gov record NCT05196750. Inclusion in this directory is not an endorsement.