Pregnancy After LEEP

描述（由申请人提供）：环形电外科切除术（LEEP）是美国治疗宫颈发育不良的常用手术，估计每年有59，000例此类手术。尽管这种手术很常见，通常在育龄妇女中进行（考虑到宫颈发育不良的年龄分布），但关于这种手术对随后怀孕的潜在影响的数据很少。鉴于子宫颈长度与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，本提案的目的是对LEEP与<34周早产之间的关联进行最大规模的观察性研究。我们提出了一个回顾性队列研究，包括妇女从9家医院（社区和三级）在特拉华州山谷。将通过计算机化的医院特定病理学数据库确定暴露于LEEP的女性（“暴露”）、接受宫颈打孔活检但未接受LEEP的女性以及既未接受LEEP也未接受打孔活检的女性（2个未暴露组）。将通过电话跟踪和联系受试者，此时患者将入组研究。将获得所有LEEP和穿刺活检前后妊娠的医疗记录，并由经过培训的摘要人员进行审查。 本研究的主要结局将是发生<34周的自发性早产（因为这些在发病率和死亡率方面最具临床相关性）。关注的次要结局包括使用其他定义的早产（<37周，<28周），自发流产，中期妊娠丢失和妊娠时间。我们还将LEEP的特征（深度，宽度）是否与早产相关<34周。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开发。这项研究将允许最佳的咨询，许多育龄妇女谁有LEEP对怀孕的影响，并可能铺平道路，为未来的干预研究如何最好地管理LEEP暴露的妇女在随后的怀孕。

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.