宫内节育器脱落的人口学、生殖和医学危险因素。
Demographic, Reproductive, and Medical Risk Factors for Intrauterine Device Expulsion.
机构信息
RTI Health Solutions, Research Triangle Park, North Carolina; Bayer OY, Espoo, Finland ; the Department of Obstetrics and Gynecology, University of Washington, and Kaiser Permanente Washington Health Research Institute, Seattle, Washington; the Department of Research & Evaluation, Kaiser Permanente Southern California, the Department of Health Systems Science and the Department of Clinical Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, the Division of Research, Kaiser Permanente Northern California, Oakland, and the Department of Obstetrics & Gynecology, Kaiser Permanente West Los Angeles Medical Center, Los Angeles, California; the Regenstrief Institute, and Indiana University, Indianapolis, Indiana; RTI Health Solutions, Waltham, Massachusetts; Bayer Pharmaceuticals, Whippany, New Jersey; and Bayer AG, Berlin, Germany .
出版信息
Obstet Gynecol. 2022 Dec 1;140(6):1017-1030. doi: 10.1097/AOG.0000000000005000. Epub 2022 Nov 2.
OBJECTIVE
To explore to what extent intrauterine device (IUD) expulsion is associated with demographic and clinical risk factors.
METHODS
The APEX-IUD (Association of Perforation and Expulsion of IntraUterine Devices) study was a U.S. cohort study using electronic health records from three integrated health care systems (Kaiser Permanente Northern California, Southern California, and Washington) and a health care information exchange (Regenstrief Institute). These analyses included individuals aged 50 years or younger with IUD insertions from 2001 to 2018. Intrauterine device expulsion cumulative incidence and incidence rates were estimated. Using Cox regression models, hazard ratios with 95% CIs were estimated before and after adjustment for risk factors of interest (age, race and ethnicity, parity, body mass index [BMI], heavy menstrual bleeding, and dysmenorrhea) and potential confounders.
RESULTS
In total, 228,834 individuals with IUD insertion and no delivery in the previous 52 weeks were identified (184,733 [80.7%] with levonorgestrel-releasing intrauterine system). Diagnosis of heavy menstrual bleeding-particularly a diagnosis in both recent and past periods-was the strongest risk factor for IUD expulsion. Categories with the highest risk of IUD expulsion within each risk factor included individuals diagnosed with overweight, obesity, and morbid obesity; those in younger age groups, especially among those aged 24 years or younger; and in those with parity of four or more. Non-Hispanic White individuals had the lowest incidence and risk, and after adjustment, Asian or Pacific Islander individuals had the highest risk. Dysmenorrhea was not independently associated with expulsion risk when adjusting for heavy menstrual bleeding.
CONCLUSION
Most risk factors for expulsion identified in this study appear consistent with known physiologic factors that affect uterine anatomy and physiology (age, BMI, heavy menstrual bleeding, parity). The increased risk of IUD expulsion among individuals of color warrants further investigation. Intrauterine devices are an effective long-term contraceptive; expulsion is uncommon, but patients should be counseled accordingly.
FUNDING SOURCE
Bayer AG.
CLINICAL TRIAL REGISTRATION
EU PAS register, EUPAS33461.
目的
探讨宫内节育器（IUD）脱落与人口统计学和临床危险因素的关系。
方法
APEX-IUD（宫内节育器穿孔和脱落协会）研究是一项美国队列研究，使用了来自三个综合医疗保健系统（加州 Kaiser Permanente、南加州 Kaiser Permanente 和华盛顿 Kaiser Permanente）和一个医疗保健信息交换（Regenstrief 研究所）的电子健康记录。这些分析包括 2001 年至 2018 年期间年龄在 50 岁或以下、有 IUD 插入史的个体。估计了 IUD 脱落的累积发生率和发生率。使用 Cox 回归模型，在调整了感兴趣的危险因素（年龄、种族和民族、产次、体重指数[BMI]、月经过多和痛经）和潜在混杂因素之前和之后，估计了风险比及其 95%置信区间。
结果
共确定了 228834 名 IUD 插入且在过去 52 周内无分娩的个体（184733 名[80.7%]为左炔诺孕酮释放宫内节育系统）。月经过多的诊断-特别是近期和过去都有诊断-是 IUD 脱落的最强危险因素。在每个危险因素中，IUD 脱落风险最高的类别包括超重、肥胖和病态肥胖的个体；年龄较小的年龄组，尤其是 24 岁或以下的个体；以及产次为四胎或更多的个体。非西班牙裔白人的发生率和风险最低，调整后，亚裔或太平洋岛民的风险最高。调整月经过多后，痛经与脱落风险无关。
结论
本研究中确定的大多数脱落危险因素似乎与影响子宫解剖和生理学的已知生理因素一致（年龄、BMI、月经过多、产次）。有色人种的 IUD 脱落风险增加需要进一步研究。宫内节育器是一种有效的长期避孕方法；脱落并不常见，但应相应地对患者进行咨询。
资金来源
拜耳公司。
临床试验注册
欧盟 PAS 注册，EUPAS33461。
Zotero 插件