Does the shape of the copper intrauterine device play a role in expulsion? Results from the ongoing European Active Surveillance Study on LCS12.

Tanja Boehnke, Anja Bauerfeind, Lisa Eggebrecht, Camille Cellier, Jens A Lange, Klaas Heinemann, Tessa Madden
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Abstract

Objective: To compare the incidence of expulsion for different copper intrauterine device (IUD) shapes.

Study design: We conducted a secondary analysis of the ongoing, prospective, non-interventional European Active Surveillance Study on LCS12 (EURAS-LCS12). Users of newly inserted IUDs were recruited in 10 European countries via a network of approximately 1200 clinicians. We restricted the analysis to copper IUD users. In the main analysis, we classified copper IUDs by shape [Nova-T frame, Tatum-T frame, Multiload frame, frameless IUDs and intrauterine balls], without differentiation of size. We calculated the cumulative incidence, crude, and adjusted hazard ratios for expulsion. Covariates included in the adjusted analyses were age, BMI, parity, education, income, IUD user status, marital status, length of device, heavy menstrual bleeding, and clinician's experience.

Results: We included 26,381 copper IUD users from the EURAS-LCS12 dataset for this study. The most frequently used IUD shape was the Nova-T frame (14,724 [55.8%]) followed by the Tatum-T frame (4276 [16.2%]), frameless IUDs (3374 [12.8%]), Multiload frame (2962 [11.2%]), and intrauterine balls (IUBs) (1045 [4.0%]). Cox regression analysis regarding expulsions yielded an adjusted hazard ratio of 0.8 (95% CI, 0.7-1.0), 1.3 (95% CI, 1.0-1.8), 1.6 (95% CI, 1.2-2.1) and 3.6 (95% CI, 2.7-4.9) for Nova-T frame IUD, frameless IUDs, Multiload frame IUDs and IUBs versus Tatum-T frame IUD, respectively.

Conclusion: The risk of expulsion following placement of a copper IUD is related to IUD shape, with Nova-T frame and Tatum-T frame IUDs demonstrating the lowest risk.

Implications: Our finding of a higher risk of expulsion observed with Multiload frame, frameless, and intrauterine ball copper IUDs compared to Tatum-T frame and Nova-T frame devices during real world use has clinical importance. Clinicians may choose to use these data when counseling patients.

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铜质宫内节育器的形状对排出有影响吗?正在进行的欧洲 LCS12 主动监测研究的结果。
研究目的比较不同形状铜质宫内节育器(IUD)的排出率:我们对正在进行的前瞻性、非干预性欧洲 LCS12 主动监测研究(EURAS-LCS12)进行了二次分析。我们在 10 个欧洲国家通过一个由约 1200 名临床医生组成的网络招募了新插入宫内节育器的用户。我们的分析仅限于铜质宫内节育器使用者。在主要分析中,我们按照铜质宫内节育器的形状[Nova-T有框架、Tatum-T有框架、Multiload有框架、无框架宫内节育器和宫内球]进行分类,而不区分其大小。我们计算了宫内节育器脱出的累积发生率、粗略危险比和调整危险比。调整分析中的协变量包括年龄、体重指数、奇偶数、教育程度、收入、宫内节育器使用者状况、婚姻状况、装置时间长短、月经大量出血和临床医生的经验:本研究从 EURAS-LCS12 数据集中纳入了 26,381 名铜宫内节育器使用者。最常用的宫内节育器形状是 Nova-T 型框架(14,724 [55.8%]),其次是 Tatum-T 型框架(4,276 [16.2%])、无框架宫内节育器(3,374 [12.8%])、Multiload 型框架(2,962 [11.2%])和宫内球(IUB)(1,045 [4.0%])。关于宫外孕的 Cox 回归分析显示,Nova-T 有框架宫内节育器、无框架宫内节育器、Multiload 有框架宫内节育器和 IUB 与 Tatum-T 有框架宫内节育器相比,调整后的危险比分别为 0.8(95% CI,0.7-1.0)、1.3(95% CI,1.0-1.8)、1.6(95% CI,1.2-2.1)和 3.6(95% CI,2.7-4.9):结论:放置铜质宫内节育器后发生宫外孕的风险与宫内节育器的形状有关,Nova-T 型宫内节育器和 Tatum-T 型宫内节育器的风险最低:我们发现,在实际使用过程中,与 Tatum-T 型和 Nova-T 型宫内节育器相比,Multiload 型、无框架型和宫内球型铜质宫内节育器的排出风险更高,这一发现具有重要的临床意义。临床医生在为患者提供咨询时可选择使用这些数据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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