Teratogenicity of drugs commonly used in pregnancy

妊娠期常用药物的致畸性

• 批准号: 7807178
• 负责人: Sonia Hernandez-Diaz
• 金额: $ 41.12万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-12-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7807178
• 关键词: Acute; Adult; Alcohol consumption; Analgesics; Anti-Infective Agents; Antibiotics; Antihistamines; Area; Asthma; Birth; Boston; Cardiovascular system; Characteristics; Child; Childhood; Chronic; Clinical; Comorbidity; Confidence Intervals; Congenital Abnormality; Coughing; Data; Databases; Decision Making; Decongestants; Defect; Development; Diabetes Mellitus; Dietary intake; Drug Prescriptions; Drug Utilization; Drug usage; Epidemiology; Exposure to; First Pregnancy Trimester; Fright; General Population; Genitourinary system; Goals; Grant; Guidelines; Health Personnel; Hospitals; Infant; Infection; International Classification of Disease Codes; Interview; Iowa; Limb structure; Logistic Regressions; Massachusetts; Medical; Modeling; Mothers; Neural Tube Defects; New York; Non-Prescription Drugs; North America; Nurses; Observational Study; Odds Ratio; Patients; Pattern; Pediatrics; Perinatal Epidemiology; Perinatal Exposure; Pharmaceutical Preparations; Pharmacoepidemiology; Pharmacology; Phase; Philadelphia; Population; Population Study; Positioning Attribute; Pregnancy; Pregnant Women; Prevalence; Public Health; Registries; Research; Risk; Risk Estimate; Risk Factors; Safety; Sampling; Savings; Secondary to; Surveillance Program; Teratology; Therapeutic; Time; Vulnerable Populations; Work; administrative database; base; case control; cigarette smoking; evidence based guidelines; experience; fetal; fetal drug exposure; improved; malformation; metropolitan; oral cleft; public health relevance; reproductive

DESCRIPTION (provided by applicant): It is ironic that decongestant, antihistamine and cough ("cough/cold") medications are among the most commonly used drugs during pregnancy, yet their safety with respect to birth defects is not established. Given the wide use of these drugs, even a small increase in the risk of birth defects may have considerable clinical and public health implications. Thus, we will evaluate the association between in utero exposure to these drugs and 1) specific major malformations previously hypothesized to be associated with each of them, and 2) other specific major malformations that occur commonly in the general population. These goals can be efficiently achieved by taking advantage of data available through a large ongoing multicenter case-control surveillance program of birth defects in North America, the Slone Epidemiology Center Birth Defects Study (BDS). The BDS has involved over 100 birth and tertiary hospitals in the greater metropolitan areas of Boston, Philadelphia, Toronto, San Diego, and selected regions in Iowa, as well as birth defects registries in Massachusetts and New York State, and has, since 1976, interviewed more than 35,000 mothers of babies with and without birth defects. The BDS identifies infants with a wide range of malformations (ICD codes 740.0-759.9) and a sample of non-malformed infants within 5 months after birth, and study nurses interview mothers within 6 months of delivery about demographic, reproductive, and medical factors; cigarette smoking and alcohol consumption; dietary intake; and details about use of a wide range of medications, including prescription over-the-counter drugs. The study has successfully identified both risks and safety of selected over-the-counter medications-findings which have been confirmed by others. We propose to first characterize the patterns of use of cough/cold medications during pregnancy and the changes in drug utilization over the study period. We then will estimate the risk of specific birth defects associated with first trimester exposure to specific decongestant, antihistamine and cough medications. Odds ratios and 95 per cent confidence intervals will be calculated using conditional logistic regression models to adjust for potential confounders. Findings from this effort will improve our understanding of risks associated with drugs commonly used by pregnant women, will inform therapeutic guidelines, and will provide leads for further research. PUBLIC HEALTH RELEVANCE: Decongestant, antihistamine and cough medications are among the most commonly used drugs during pregnancy, but the safety of these medications with respect to birth defects is not established. This study will evaluate whether use of these drugs in pregnancy is associated with an increased risk of major birth defects. Findings will improve our understanding of risks associated with these drugs, will help health care providers and pregnant women make informed choices, and will provide leads for further research.

描述（由申请人提供）：具有讽刺意味的是，充血，抗组胺药和咳嗽（“咳嗽/冷”）药物是怀孕期间最常用的药物之一，但尚未确定它们在先天缺陷方面的安全性。鉴于这些药物的广泛使用，即使出生缺陷的风险也很小的临床和公共卫生影响也很小。因此，我们将评估子宫内暴露于这些药物的关联和1）先前假设与每个药物相关的特定主要畸形，以及2）其他普通人群中通常发生的其他特定主要畸形。通过利用北美的大型多中心病例对照监视计划可用的数据，可以通过利用可用的数据来有效实现这些目标，北美的先天缺陷计划，Slone Epidemiology Center中心出生缺陷研究（BDS）。 BDS在波士顿，费城，多伦多，多伦多，圣地亚哥和爱荷华州的大都市地区涉及100多个出生和三级医院，以及在马萨诸塞州和纽约州的出生缺陷的注册表，自1976年以来，自1976年以来就接受了超过35,000名与生育缺陷相比的母亲。 BDS在出生后5个月内鉴定出具有广泛畸形（ICD代码740.0-759.9）的婴儿（ICD代码740.0-759.9），并在分娩后6个月内对母亲进行了研究护士在人口统计学，生殖，生殖和医疗因素后的6个月内采访母亲；吸烟和饮酒；饮食摄入；以及有关使用多种药物的详细信息，包括处方非处方药。该研究成功地确定了其他人确认的选定非处方药的风险和安全性。我们建议首先要表征怀孕期间咳嗽/冷药物使用的模式以及在研究期间的药物利用变化。然后，我们将估计与特定缺乏症，抗组胺药和咳嗽药物相关的特定先天缺陷的风险。赔率和95％的置信区间将使用条件逻辑回归模型计算，以调整潜在的混杂因素。这项工作的结果将提高我们对与孕妇常用的药物相关的风险的理解，将为治疗指南提供信息，并将为进一步研究提供潜在客户。公共卫生的相关性：缺乏症，抗组胺药和止咳药是怀孕期间最常用的药物之一，但是这些药物在先天​​缺陷方面的安全性尚未确定。这项研究将评估这些药物在怀孕中的使用是否与重大先天缺陷的风险增加有关。调查结果将提高我们对与这些药物相关的风险的理解，将帮助医疗保健提供者和孕妇做出明智的选择，并为进一步的研究提供潜在客户。