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Comparative Safety of commonly prescribed Psychotropic Drugs in pregnant Women

孕妇常用精神药物的比较安全性

基本信息

批准号：
8632198
负责人：
Sonia Hernandez-Diaz
金额：
$ 53.13万
依托单位：
HARVARD SCHOOL OF PUBLIC HEALTH
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-05-01 至 2017-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8632198
关键词：
Accounting Address Admission activity Adverse event Airborne Particulate Matter Alcohols Anticonvulsants Antidepressive Agents Antiepileptic Agents Antipsychotic Agents Anxiety Attention deficit hyperactivity disorder Bayesian Method Benefits and Risks Benzodiazepines Bipolar Disorder Birth Cesarean section Characteristics Conceptions Confidence Intervals Congenital Heart Defects Databases Development Discipline of obstetrics Dose Drug usage Eclampsia Effectiveness Epidemiology Epilepsy Event Exposure to Female of child bearing age Fetal Growth Retardation Fetus Gestational Diabetes Goals Growth High Prevalence Hospital Departments Hospitalization Incidence Indigent Infant Knowledge Learning Low Birth Weight Infant Medicaid Medical Medical Records Mental disorders Modeling Modification Mood Disorders Mood stabilizers Mothers National Health and Nutrition Examination Survey Neonatal Neonatal Abstinence Syndrome Neurologic Newborn Infant Obesity Outcome Patients Pattern Pharmaceutical Preparations Physicians Population Population Study Postpartum Hemorrhage Pre-Eclampsia Pregnancy Pregnant Women Premature Birth Psyche structure Psychotic Disorders Psychotropic Drugs Public Health Schools Recommendation Records Relapse Relative (related person)Relative Risks Research Risk Safety Schizophrenia Seizures Smoking Subgroup Symptoms Techniques Therapeutic Toxic effect Unplanned pregnancy Withdrawal Symptom Woman Work base clinical practice clinically relevant cohort comparative effectiveness clinical trial evidence based guidelines experience fetal innovation interdisciplinary collaboration lamotrigine malformation neonatal death offspring oral cleft population based pregnancy hypertension pregnant prenatal exposure psychostimulant public health relevance respiratory topiramate trend valproate young woman

项目摘要

ABSTRACT Mental illnesses complicate over 15% of all pregnancies. Many of these conditions require treatment with psychotropic drugs. However, multiple studies have suggested an association between prenatal exposure to psychotropic drugs and an increased risk of major malformations, growth restriction, neonatal withdrawal syndrome and respiratory problems in the newborn, as well as gestational diabetes, preeclampsia and cesarean section in the mother. On the other hand, pregnant women with mental and/or neurological conditions who discontinue therapy may experience relapse of symptoms that can be dangerous for them and their offspring. Because many of these conditions require pharmacologic treatment and many pregnancies are unplanned, the clinically relevant questions are 1) which specific medication to recommend for women of childbearing age and 2) whether and when to discontinue treatment during pregnancy. Despite the difficult decisions faced by patients and physicians, sufficient information to guide therapeutic recommendations for the use of psychotropic drugs during pregnancy is lacking. Even when these medications may be safe, the lack of knowledge may instill unnecessary anxiety in pregnant women. Our primary objective is to provide direct evidence on the comparative safety of specific strategies used to manage mood disorders, psychosis, and attention deficit hyperactivity disorders (ADHD) in a population of pregnant women, which includes vulnerable indigent young women. We hypothesize that not all drugs are equal and that the risk-benefit trade- off of continuing treatment during pregnancy will differ by drug. We propose to quantify the risk of maternal and fetal adverse events associated with continuing and discontinuing specific psychotropic drugs during pregnancy. Within both the Medicaid Analytic eXtract (MAX) and the UnitedHealth Research database, two large population-based claims databases linkable to additional obstetrical, birth, and psychiatric records, we will identify cohorts of over 18,500 women on mood stabilizers (antiepileptics), 6,500 on antipsychotics, and 3,000 on psychostimulants at conception who delivered between 2000 and 2012. Relative risks and 95% confidence intervals will be calculated using regression models that account for the possible correlation induced by multiple gestations. We will apply an innovative combination of high dimensional propensity score techniques, instrumental variables and external adjustment to minimize the potential for confounding, and Bayesian approaches to account for prior information and support patient subgroup analyses. We will obtain information from medical records to validate specific outcomes and from the National Health and Nutrition Examination Survey to obtain information on potential confounders such as smoking, alcohol and obesity. The current proposal is an interdisciplinary collaboration between the Brigham and Women's Hospital and the Department of Epidemiology at Harvard School of Public Health.

摘要超过15%的孕妇患有精神疾病。其中许多情况需要治疗，精神药物然而，多项研究表明，产前暴露于精神药物和重大畸形、生长受限、新生儿戒断的风险增加综合征和新生儿呼吸问题，以及妊娠糖尿病，先兆子痫和母亲的剖腹产。另一方面，患有精神和/或神经系统疾病的孕妇停止治疗的病症可能会出现对他们来说可能是危险的症状复发，他们的后代。因为许多这些条件需要药物治疗和许多怀孕是计划外，临床相关的问题是1）哪些具体的药物建议妇女育龄和2）妊娠期间是否以及何时停止治疗。面对困难患者和医生面临的决策，足够的信息来指导治疗建议，在怀孕期间没有使用精神药物。即使这些药物可能是安全的，缺乏知识的缺乏可能会给孕妇带来不必要的焦虑。我们的主要目标是提供直接证据表明，用于管理情绪障碍，精神病，和注意力缺陷多动障碍（ADHD）的孕妇人群，其中包括脆弱的贫穷年轻女性。我们假设不是所有的药物都是平等的，风险收益交易- 在怀孕期间停止继续治疗将因药物而异。我们建议量化孕产妇和胎儿不良事件与持续和停用特定精神药物相关怀孕在Medicaid Analytic eXtract（MAX）和UnitedHealth Research数据库中，大量基于人口的索赔数据库，除了额外的产科，出生和精神病记录，我们将确定超过18,500名服用情绪稳定剂（抗癫痫药）的女性，6,500名服用抗精神病药的女性，在2000年到2012年之间分娩的3,000人在怀孕时服用了精神兴奋剂。相对风险和95% 将使用考虑可能相关性的回归模型计算置信区间由多次怀孕引起的。我们将应用一个创新的组合，高维倾向得分技术、工具变量和外部调整，以尽量减少混淆的可能性，以及贝叶斯方法用于解释先验信息并支持患者亚组分析。我们将获得来自医疗记录的信息，以验证特定的结果，并从国家健康和营养检查调查，以获得潜在混杂因素的信息，如吸烟、饮酒和肥胖目前的建议是布里格姆妇女医院之间的跨学科合作以及哈佛公共卫生学院的流行病学系。