Non-steroidal anti-inflammatory use and miscarriage

非甾体抗炎药的使用和流产

• 批准号: 7447624
• 负责人: KATHERINE E HARTMANN
• 金额: $ 22.46万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7447624
• 关键词: clinical research; disease /disorder proneness /risk; drug administration rate /duration; embryo /fetus drug adverse effect; embryo /fetus monitoring; female; gestational age; human pregnant subject; human subject; interview; karyotype; nonsteroidal antiinflammatory agent; personal log /diary; spontaneous abortion; ultrasonography; women' s health

DESCRIPTION (provided by applicant): Thirty-nine percent of reproductive age women have used a non-steroidal anti-inflammatory drug (NSAID) in the past week, and NSAIDs are the most frequent medication exposure in the first trimester of pregnancy. The safety of NSAID use in early pregnancy is uncertain. Our objective is to examine prospectively the association of NSAID use with spontaneous abortion. We propose to enroll women who are planning a pregnancy and obtain daily diaries of medication use, symptoms (indications) and other key confounders during the period while participants are attempting to conceive. Among the first 1,200 women who become pregnant, we will continue to collect daily diary information through the 12th week of pregnancy, obtain an early pregnancy ultrasound in the sixth week, and conduct an extensive computer assisted telephone interview at 13 weeks. Birth outcomes will be documented for all pregnancies and karyotyping will be done on all losses where a tissue specimen is available. These methods will allow us to answer our primary research questions: (1) Is NSAID use independently associated with increased risk of spontaneous abortion? (2) Does the association of NSAIDs with spontaneous abortion depend on cumulative dose, regular versus episodic use, and/or exposure during critical developmental windows? and these secondary questions: (3) Are common indications for NSAID use independently associated with spontaneous abortion? (4) Does developmental stage attained prior to spontaneous abortion differ between exposed and unexposed pregnancies? The primary tools for the proposed study are already in place including successful approaches to community-based recruitment prior to pregnancy, ultrasound forms and protocols, computer assisted telephone interviews, data management and quality control systems and experienced staff. Costly piloting and implementation phases have been completed. In short, we are fully prepared to efficiently address pressing questions about NSAID exposure in early pregnancy by conducting a large-scale, fully-prospective cohort study. If NSAID use has an adverse effect on early pregnancy outcomes, the public health impact would be substantial. For example, if NSAID exposure increases relative risk by 50 per cent, and 19 per cent of women use NSAIDs during the first trimester of pregnancy (a conservative estimate based on retrospective data), then over 80,000 spontaneous abortions could be attributed to NSAIDs each year in the United States.

描述（由申请人提供）：过去一周中，有39％的生殖年龄妇女使用了非甾体类抗炎药（NSAID），而NSAID是怀孕前期最常见的药物暴露。 NSAID在怀孕早期的安全性尚不确定。我们的目标是前瞻性地检查NSAID使用与自发流产的关联。我们建议在参与者试图怀孕的时候，招募计划怀孕并获得用药，症状（适应症）和其他主要混杂因素的日记。在怀孕的前1,200名妇女中，我们将在怀孕的第12周内继续收集每日日记信息，在第六周获得早期怀孕超声检查，并在13周内进行大量的计算机辅助电话采访。将记录所有怀孕的出生结果，并将在可用的组织标本的所有损失上进行核分型。这些方法将使我们能够回答我们的主要研究问题：（1）NSAID是否与自发流产的风险增加独立相关？ （2）NSAID与自发流产的关联是否取决于累积剂量，定期使用与情节使用和/或关键发育窗口期间暴露？这些次要问题：（3）是与自发流产独立相关的NSAID使用的常见指示吗？ （4）在自发堕胎之前达到的发育阶段在暴露和未暴露的怀孕之间是否有所不同？拟议研究的主要工具已经到位，包括在怀孕之前成功的基于社区招聘的方法，超声形式和协议，计算机辅助电话访谈，数据管理和质量控制系统以及经验丰富的员工。昂贵的试点和实施阶段已经完成。简而言之，我们已经准备好通过进行大规模，全面的队列研究来有效地解决有关怀孕早期NSAID暴露的紧迫问题。如果NSAID使用对早期妊娠结局产生不利影响，那么公共卫生的影响将是巨大的。例如，如果NSAID暴露将相对风险增加50％，而19％的妇女在怀孕的头三个月（基于回顾性数据的保守估计）中使用NSAID，那么在美国，每年可能将超过80,000个自发流产归因于NESAID。