Pregnancy After LEEP

描述(由申请人提供)：环状电刀切除手术(LEEP)是美国治疗宫颈发育不良的常用手术，每年估计有59,000例此类手术。尽管这种手术很常见，而且通常是在育龄妇女身上进行的(考虑到宫颈发育不良的年龄分布)，但关于这种手术对后续怀孕的潜在影响的数据很少。鉴于宫颈长度和早产之间的既定关系，LEEP可能会增加早产和其他不良妊娠结局的风险。因此，这项提案的目的是对LEEP和早产及34周之间的关系进行最大规模的观察性研究。我们建议进行一项回溯性队列研究，包括来自特拉华河谷9家医院(社区和三级医院)的妇女。暴露于LEEP的妇女(“暴露”)，没有接受LEEP的宫颈穿孔活检的妇女，以及既没有接受LEEP也没有进行穿孔活检的妇女(两个非暴露组)将通过计算机化的、特定于医院的病理数据库来确定。受试者将被跟踪并通过电话联系，届时患者将被纳入研究。所有LEEP术前、术后和PACK活体检查妊娠的医疗记录将由训练有素的抽象员获得和审查。 这项研究的主要结果将是自然早产的发生&34周(因为在发病率和死亡率方面，这是最具临床相关性的)。感兴趣的次要结果包括使用其他定义的早产(&lt；37周、&lt；28周)、自发流产、中期妊娠丢失和妊娠持续时间。我们还将探讨LEEP的特征(深度、宽度)是否与早产及34周相关。分析计划将包括双变量和多变量技术，以及临床预测规则的发展。这项研究将允许对许多接受LEEP的育龄妇女就其对怀孕的影响进行最佳咨询，并可能为未来关于如何最好地管理后续怀孕中暴露于LEEP的妇女的干预研究铺平道路。

DESCRIPTION (provided by applicant): Loop Electrosurgical Excision Procedure (LEEP) is a commonly performed procedure for the treatment of cervical dysplasia in the U.S., with an estimated 59,000 such procedures per year. Despite the fact that this procedure is common and is performed usually on women of reproductive age (given the age distribution of cervical dysplasia), there are few data on the potential impact of this procedure on subsequent pregnancy. Given the established relationship between the length of the cervix and preterm birth, it is plausible that LEEP may increase the risk of preterm birth and other adverse pregnancy outcomes. Thus, the aim of this proposal is to perform the largest observational study of the association between LEEP and preterm birth <34 weeks. We propose a retrospective cohort study, including women from 9 hospitals (community and tertiary) in the Delaware Valley. Women exposed to LEEP ("exposed"), women who have had a cervical punch biopsy without LEEP, and women with neither a LEEP nor punch biopsy (2 unexposed groups) will be ascertained by computerized, hospital specific pathology databases. Subjects will be tracked and contacted via phone, at which time patients will be enrolled into the study. The medical records of all pre and post-LEEP and punch biopsy pregnancies will be obtained and reviewed by trained abstractors. The primary outcome for this study will be the occurrence of a spontaneous preterm birth <34 weeks (since these are most clinically relevant in terms of morbidity and mortality). Secondary outcomes of interest include preterm birth using other definitions (<37 weeks, <28 weeks), spontaneous miscarriage, midtrimester pregnancy loss, and length of gestation. We will also whether characteristics of the LEEP (depth, width) are associated with preterm birth <34 weeks. The analytic plan will include bivariate and multivariate techniques, and the development of a clinical prediction rule. This study will allow for optimal counseling of the many reproductive-aged women who have had LEEP about the impact on pregnancy, and may pave the way for future interventional studies of how best to manage LEEP-exposed women in a subsequent pregnancy.