Lisa Eggebrecht, Anja Bauerfeind, Tanja Boehnke, Manuel Rizzo, Christine Hagemann, Jens Lange, Mareike Viet, Karl Pauls, Sophia von Stockum, Moritz Klinghardt, Klaas Heinemann
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A great variety of baseline characteristics and endpoints are assessed in patient-reported questionnaires. The follow-up duration aligns with the intended maximum duration of use of 3 to 5 years, depending on the respective IUD.</p><p><strong>Results: </strong>Currently, 97,187 users are enrolled in the study, of whom the vast majority uses IUDs for contraceptive purposes (96.3%), and roughly two thirds are first-time IUD users (64.1%). Heavy menstrual bleeding (HMB) was reported as the second most common reason for IUD use but with apparent variations between devices and countries. Mean age of LNG-IUD 8 users was about 9 years lower compared with LNG-IUD 20 (26.2 vs. 34.6 years). Greatest differences in the proportion of gravid and parous women were observed between LNG-IUS 8 and OHIUD users (gravid: 38.6% vs. 89.8%; para: 30.6% vs. 88.0%).</p><p><strong>Conclusions: </strong>With more than 97,000 IUD users, EURAS-LCS12 is one of the largest contemporary studies focusing on IUD usage and provides a substantial source of real-world data. IUD prescription patterns appear in line with assumptions that high-dose LNG-IUDs with longer approved durations of use are predominantly prescribed among older, gravid women, who may have completed their family planning, as opposed to younger nulligravidae. 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引用次数: 0
摘要
背景：欧洲LCS12主动监测研究（EURAS-LCS12）调查了宫内节育器（iud）在常规临床实践中的有效性和安全性。在这里，我们的目标是描述在现实世界中记录的全欧洲宫内节育器使用者的一般人群。EURAS-LCS12是一项前瞻性、非干预性队列研究，从2014年开始在10个欧洲国家开展。纳入所有批准的宫内节育器：左炔诺孕酮(LNG)-IUS 8 (LNG释放率~ 8µg/day)；LNG- ius 12 (LNG释放率~ 12µg/天；LNG- ius 20 （LNG释放率~ 20µg/天；）;铜宫内节育器和其他激素宫内节育器（OHIUD）在患者报告的问卷中评估了各种基线特征和终点。随访时间与预期的最长使用时间3 - 5年保持一致，具体取决于各自的宫内节育器。结果：目前，共有97187名使用者参加了这项研究，其中绝大多数使用宫内节育器进行避孕（96.3%），大约三分之二是首次使用宫内节育器（64.1%）。大量月经出血（HMB）被报道为使用宫内节育器的第二大常见原因，但在不同的装置和国家之间存在明显差异。LNG-IUD 8使用者的平均年龄比LNG-IUD 20使用者低约9岁（26.2岁比34.6岁）。使用LNG-IUS 8和使用OHIUD的孕妇和产妇比例差异最大(孕妇：38.6% vs 89.8%；Para: 30.6%对88.0%)。结论：EURAS-LCS12共有97,000多名宫内节育器使用者，是当代最大的关注宫内节育器使用的研究之一，并提供了大量真实数据来源。宫内节育器的处方模式似乎符合这样的假设，即批准使用时间较长的大剂量液化天然气宫内节育器主要用于可能已完成计划生育的高龄妊娠妇女，而不是年轻的无孕妇女。总的来说，这项研究是描述哪种类型的宫内节育器适合女性在生命的某个时期的某些特征和需求的重要来源。试验注册：NCT02146950。
Population characteristics of intrauterine device users in real-world clinical practice across Europe - insights from the EURAS-LCS12 study.
Background: The European Active Surveillance Study of LCS12 (EURAS-LCS12) investigates effectiveness and safety of intrauterine devices (IUDs) in routine clinical practice. Here, we aim to characterise the general population of IUD users across Europe recorded in a real-world setting.
Methods: EURAS-LCS12 is a prospective, non-interventional cohort study in ten European countries, that started in 2014. All types of approved IUDs were enrolled: levonorgestrel (LNG)-IUS 8 (LNG release rate ~ 8 µg/day); LNG-IUS 12 (LNG release rate ~ 12 µg/day; LNG-IUS 20 (LNG release rate ~ 20 µg/day; ); copper IUDs and other hormonal IUDs (OHIUD). A great variety of baseline characteristics and endpoints are assessed in patient-reported questionnaires. The follow-up duration aligns with the intended maximum duration of use of 3 to 5 years, depending on the respective IUD.
Results: Currently, 97,187 users are enrolled in the study, of whom the vast majority uses IUDs for contraceptive purposes (96.3%), and roughly two thirds are first-time IUD users (64.1%). Heavy menstrual bleeding (HMB) was reported as the second most common reason for IUD use but with apparent variations between devices and countries. Mean age of LNG-IUD 8 users was about 9 years lower compared with LNG-IUD 20 (26.2 vs. 34.6 years). Greatest differences in the proportion of gravid and parous women were observed between LNG-IUS 8 and OHIUD users (gravid: 38.6% vs. 89.8%; para: 30.6% vs. 88.0%).
Conclusions: With more than 97,000 IUD users, EURAS-LCS12 is one of the largest contemporary studies focusing on IUD usage and provides a substantial source of real-world data. IUD prescription patterns appear in line with assumptions that high-dose LNG-IUDs with longer approved durations of use are predominantly prescribed among older, gravid women, who may have completed their family planning, as opposed to younger nulligravidae. Overall, the study is a great source to depict which IUD type fits women with certain characteristics and needs at a certain time of life.
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