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Maternal epilepsy, antiepileptic drug use during pregnancy, and risk of autism

孕产妇癫痫、怀孕期间抗癫痫药物的使用以及自闭症的风险

基本信息

批准号：
9816282
负责人：
Brian Kane Lee
金额：
$ 50.67万
依托单位：
DREXEL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-06-01 至 2023-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9816282
关键词：
Address Adult Adverse effects Affect Antiepileptic Agents Area Benefits and Risks Caring Cause of Death Cesarean section Cessation of life Child Clinical Cognition Congenital Abnormality Data Databases Drug Exposure Drug usage Epilepsy Ethics Etiology Exposure to Fetus Frequencies Fright General Population Genetic Hospitalization Link Literature Maternal Health Mental disorders Methodology Methods Molecular Morbidity - disease rate Mothers Observational Study Outcome Pain Disorder Patients Persons Pharmaceutical Preparations Pharmacoepidemiology Phenotype Population Database Pre-Eclampsia Pregnancy Pregnancy Outcome Pregnant Women Premature Labor Prevalence Public Health Randomized Controlled Trials Recommendation Reporting Research Risk Risk Estimate Risk Reduction Safety Sample Size Sampling Seizures Selection Bias Self-Injurious Behavior Siblings Statistical Methods Status Epilepticus Sweden Techniques Time Tonic - clonic seizures United Kingdom Woman autism spectrum disorder clinical database clinical practice computerized disorder risk epidemiology study evidence base health data improved interest mortality risk motor impairment nervous system disorder neurodevelopment population based prenatal exposure prevent risk benefit ratio simulation stillbirth valproate

项目摘要

Project Abstract In a multi-national epidemiological study in Sweden and the United Kingdom, we aim to study if maternal epilepsy and use of anti-epileptic drugs (AEDs) during pregnancy is associated with increased risk of autism spectrum disorders (ASD). In addition, we will examine maternal health outcomes associated with AED use to provide data regarding the risk-benefit ratio of continuing medication use during pregnancy. Epilepsy is the most common serious neurological disorder affecting women during pregnancy, and is linked with a 10-fold increased risk of death during delivery. Antiepileptic drugs are necessary for seizure control, but effects of AED use during pregnancy remain understudied. Although there is good evidence linking use of AEDs during pregnancy to congenital malformations, there is less high-quality evidence concerning adverse neurodevelopmental outcomes. Two studies have found an association between AED exposure during pregnancy and ASD, but both studies had fewer than 10 ASD cases exposed to AEDs. Moreover, many studies of AEDs and neurodevelopmental outcomes have methodological issues. Two review of past studies of neurodevelopmental outcomes in children exposed to AEDs found substantial problems that prevented definitive conclusions regarding adverse effects of AED exposure. The chief problems included: confounding, selection bias, and small sample sizes with limited statistical power. We propose an epidemiological study that addresses each of these issues, in a combined sample of nearly 3 million children born in Sweden and the United Kingdom. All exposure, confounder, and outcome data are derived from clinical and population databases in Sweden and the UK. In Aim 1 we will estimate associations of maternal epilepsy and child ASD. In Aim 2, we evaluate the safety of AED use and of specific AEDs during pregnancy with regard to child ASD. In Aim 3, we will estimate the risk or risk reduction of pregnancy and delivery outcomes associated with AED use during pregnancy, such as seizure, self-harm, or death. Throughout all analyses, causal inference techniques will be employed to determine the validity of findings. Methods include propensity score matching, sibling and negative controls, and simulation of unobserved confounders.

项目摘要