Prenatal NSAID Use and Miscarriage

描述（由申请人提供）：最近的报告显示，妊娠期间使用非甾体抗炎药（NSAID）会增加自然流产的风险。为了进一步研究这种关联，我们建议在Kaiser Permanente医疗保健计划（KPMCP）的成员中进行队列研究。所有在13家KPMCP机构之一进行的妊娠试验呈阳性的KPMCP女性，以及会说英语或西班牙语的女性，将接受妊娠期间使用NSAID的筛查，以确定NSAID暴露的女性。使用早期电磁场暴露和自然流产风险研究中开发的方法，我们将招募1500名孕妇：500名暴露于NSAID的女性和500名未暴露的女性;为了控制适应症的混淆，我们还将招募500名使用过对乙酰氨基酚的女性，但既不是NSAID也不是阿司匹林，因为对乙酰氨基酚与NSAID有许多相似的适应症，但具有不同的药理作用。产前NSAID使用和其他药物的详细信息将在确定阳性妊娠后立即进行面对面访谈。在妊娠结束或妊娠20周时，将进一步确定访视后任何后续NSAID使用情况。自我报告的NSAID使用情况将通过药瓶、处方记录和KPMCP药房数据库进行确认，该数据库收集了在KPMCP药房获得的所有处方NSAID和非处方NSAID。自然流产和其他妊娠结果将通过与KPMCP数据库的连接和医疗记录的审查来确定。未确定的妊娠结局将通过后续电话访谈确定。将使用考克斯比例风险回归分析与孕周使用NSAID相关的自然流产风险。此外，还将检查与NSAID使用剂量、时间和持续时间相关的风险以及NSAID使用的其他特征，包括当前/既往使用和累积剂量。这项研究将是第一个基于人群的前瞻性队列研究，专门用于检查产前使用NSAID相关的自然流产风险。由于NSAID在一般人群和育龄妇女中的广泛使用，本研究的结果将提供关于围受孕期使用NSAID的安全性的有价值信息，这些信息具有显著的公共卫生意义。

DESCRIPTION (provided by applicant): Recent reports have revealed an increased risk of spontaneous abortion associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) during pregnancy. To further examine this association, we propose to conduct a cohort study among the members of the Kaiser Permanente Medical Care Program (KPMCP). All KPMCP women who have a positive pregnancy test performed in one of the 13 KPMCP facilities and who speak either English or Spanish will be screened for their NSAID use during pregnancy to identify NSAID-exposed women. Using methods developed in an earlier study of electromagnetic field exposure and the risk of spontaneous abortion, we will recruit 1500 pregnant women: 500 NSAID-exposed women and 500 unexposed women; to control for confounding by indication, we will also recruit 500 women who have used acetaminophen, but neither NSAIDs nor aspirin because acetaminophen shares many similar indications with NSAIDs, but has a different pharmacological effect. Detailed information on prenatal NSAID use and other medications will be ascertained during an in-person interview as soon as the positive pregnancy is identified. Any subsequent NSAID use after the interview will be further ascertained at the end of pregnancy or at 20 weeks of gestation. Self-reported NSAID use will be confirmed by medication bottles, prescription records, and the KPMCP pharmacy databases that capture all prescription NSAIDs and nonprescription NSAID obtained at KPMCP pharmacies. Spontaneous abortion and other pregnancy outcomes will be ascertained through linkage to the KPMCP databases and review of medical records. Unidentified pregnancy outcomes will be ascertained through follow-up telephone interviews. Cox proportional hazard regression will be used to examine the risk of spontaneous abortion associated with periconceptional NSAID use. In addition, the risk associated with dose, timing, and duration of NSAID use as well as other characteristics of NSAID use including current/past use and cumulative dose will be examined. The proposed study will be the first population-based prospective cohort study specifically designed to examine the risk of spontaneous abortion associated with prenatal NSAID use. The findings from this study will provide valuable information on the safety of periconceptional NSAID use that has significant public health implications because of the widespread use of NSAIDs in the general population and among women of reproductive age.