Abstract：
OBJECTIVE: The purpose of this study was to analyse the impact of embedment of side arms of the levonorgestrel 52 mg intrauterine device (LNG-IUD) in the myometrium (assessed by three-dimensional transvaginal ultrasound (3D-TVUS)) on uterine bleeding and pain.
METHODS: We performed a prospective cohort study in a large Dutch teaching hospital between February 2015 and December 2016. Participants over 18 years of age who selected a LNG-IUD for contraception or because of heavy menstrual bleeding were eligible for inclusion. Six weeks after insertion, a 3D-TVUS was performed to diagnose embedment of the side arms. At that moment participants filled in questionnaires about their bleeding pattern and pelvic pain. Menstruation patterns \'no bleeding\', \'regular menstruation\', \'sometimes a day of spotting (maximum once a week)\' were classified as favourable bleeding pattern. Menstruation patterns \'heavy menstrual bleeding\', \'several days a week bleeding days\', \'several days a week spotting days\', \'continuously spotting\', and \'completely irregular cycle\' were classified as unfavourable bleeding pattern. Univariate and multivariate logistic regression analysis was used to calculate odds ratios (OR) and 95 %-confidence intervals (CI). The multivariate analysis included endometrial thickness, reason for insertion and parity. The analysis of pelvic pain additionally included previous insertion.
RESULTS: A total of 220 participants were evaluated for the study of whom 176 returned the questionnaires. Embedment of the side arms was observed in 43 of the 176 responding participants (24.4 %). Favourable bleeding pattern was reported by 25/43 (58.1 %) participants with embedment and 53/133 (39.8 %) participants without embedment (ORadj 1.8, 95 % CI 0.9-3.9). Pelvic pain was reported by 4/43 (9.3 %) participants with embedment and 24/133 (18.1 %) participants without embedment (ORadj 0.3; CI 0.1-1.2).
CONCLUSIONS: The present study suggests that embedment of the side arms of the LNG-IUD in the myometrium assessed by 3D-TVUS is not associated with a unfavourable bleeding pattern nor pelvic pain six weeks after insertion. From this point of view, we do not recommend to perform standard 3D-TVUS for the purpose of excluding or demonstrating embedment.
METHODS: We performed a prospective cohort study in a large Dutch teaching hospital between February 2015 and December 2016. Participants over 18 years of age who selected a LNG-IUD for contraception or because of heavy menstrual bleeding were eligible for inclusion. Six weeks after insertion, a 3D-TVUS was performed to diagnose embedment of the side arms. At that moment participants filled in questionnaires about their bleeding pattern and pelvic pain. Menstruation patterns \'no bleeding\', \'regular menstruation\', \'sometimes a day of spotting (maximum once a week)\' were classified as favourable bleeding pattern. Menstruation patterns \'heavy menstrual bleeding\', \'several days a week bleeding days\', \'several days a week spotting days\', \'continuously spotting\', and \'completely irregular cycle\' were classified as unfavourable bleeding pattern. Univariate and multivariate logistic regression analysis was used to calculate odds ratios (OR) and 95 %-confidence intervals (CI). The multivariate analysis included endometrial thickness, reason for insertion and parity. The analysis of pelvic pain additionally included previous insertion.
RESULTS: A total of 220 participants were evaluated for the study of whom 176 returned the questionnaires. Embedment of the side arms was observed in 43 of the 176 responding participants (24.4 %). Favourable bleeding pattern was reported by 25/43 (58.1 %) participants with embedment and 53/133 (39.8 %) participants without embedment (ORadj 1.8, 95 % CI 0.9-3.9). Pelvic pain was reported by 4/43 (9.3 %) participants with embedment and 24/133 (18.1 %) participants without embedment (ORadj 0.3; CI 0.1-1.2).
CONCLUSIONS: The present study suggests that embedment of the side arms of the LNG-IUD in the myometrium assessed by 3D-TVUS is not associated with a unfavourable bleeding pattern nor pelvic pain six weeks after insertion. From this point of view, we do not recommend to perform standard 3D-TVUS for the purpose of excluding or demonstrating embedment.
摘要：
目的：本研究的目的是分析左炔诺孕酮52mg宫内节育器（LNG-IUD）侧臂嵌入子宫肌层（通过三维经阴道超声（3D-TVUS）评估）对子宫出血和疼痛的影响。
方法：我们于2015年2月至2016年12月在荷兰一家大型教学医院进行了一项前瞻性队列研究。18岁以上的参与者选择了LNG-IUD进行避孕或由于月经大量出血而被纳入。插入后六周，进行了3D-TVUS以诊断侧臂的嵌入。那时，参与者填写了有关他们的出血模式和骨盆疼痛的问卷。月经模式\'无出血\',\'月经规律\',“有时一天的斑点（每周最多一次）”被归类为有利的出血模式。月经模式\“月经大出血”，\'一周几天出血\',\'一周几天发现天\',\'不断发现\',和“完全不规则的周期”被归类为不利的出血模式。使用单变量和多变量逻辑回归分析来计算比值比（OR）和95％置信区间（CI）。多变量分析包括子宫内膜厚度，插入和奇偶校验的原因。骨盆疼痛的分析还包括先前的插入。
结果：总共对220名参与者进行了评估，其中176人返回了问卷。176名响应参与者中有43名（24.4％）观察到侧臂嵌入。25/43（58.1％）有嵌入的参与者和53/133（39.8％）无嵌入的参与者报告了良好的出血模式（ORadj1.8，95％CI0.9-3.9）。4/43（9.3％）有嵌入的参与者和24/133（18.1％）没有嵌入的参与者报告了盆腔疼痛（ORadj0.3；CI0.1-1.2）。
结论：本研究表明，通过3D-TVUS评估，将LNG-IUD侧臂嵌入子宫肌层与不良出血模式或盆腔疼痛无关。从这个角度来看,我们不建议为了排除或演示嵌入而执行标准3D-TVUS。
方法：我们于2015年2月至2016年12月在荷兰一家大型教学医院进行了一项前瞻性队列研究。18岁以上的参与者选择了LNG-IUD进行避孕或由于月经大量出血而被纳入。插入后六周，进行了3D-TVUS以诊断侧臂的嵌入。那时，参与者填写了有关他们的出血模式和骨盆疼痛的问卷。月经模式\'无出血\',\'月经规律\',“有时一天的斑点（每周最多一次）”被归类为有利的出血模式。月经模式\“月经大出血”，\'一周几天出血\',\'一周几天发现天\',\'不断发现\',和“完全不规则的周期”被归类为不利的出血模式。使用单变量和多变量逻辑回归分析来计算比值比（OR）和95％置信区间（CI）。多变量分析包括子宫内膜厚度，插入和奇偶校验的原因。骨盆疼痛的分析还包括先前的插入。
结果：总共对220名参与者进行了评估，其中176人返回了问卷。176名响应参与者中有43名（24.4％）观察到侧臂嵌入。25/43（58.1％）有嵌入的参与者和53/133（39.8％）无嵌入的参与者报告了良好的出血模式（ORadj1.8，95％CI0.9-3.9）。4/43（9.3％）有嵌入的参与者和24/133（18.1％）没有嵌入的参与者报告了盆腔疼痛（ORadj0.3；CI0.1-1.2）。
结论：本研究表明，通过3D-TVUS评估，将LNG-IUD侧臂嵌入子宫肌层与不良出血模式或盆腔疼痛无关。从这个角度来看,我们不建议为了排除或演示嵌入而执行标准3D-TVUS。
