Maastricht University Centre, Maastricht, the Netherlands.
Máxima Medical Centre, Veldhoven, the Netherlands.
BJOG. 2017 Jan;124(2):299-305. doi: 10.1111/1471-0528.14445.
The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle.
A stratified two-armed non-inferiority randomised controlled trial.
Large teaching hospital in Veldhoven, the Netherlands.
From October 2013 to May 2014, 60 nulliparous and 60 multiparous women were randomised. Eight women withdrew after randomisation and before insertion took place: therefore, data from 112 women were collected and analysed.
Women were randomised to the groups 'during menstruation' (i.e. days 1-7 of menstruation) or 'outside menstruation' (i.e. any day of the cycle after menstruation without the presence of vaginal blood loss) in a ratio of 1 : 1.
The primary outcome was pain during insertion, measured by the visual analogue scale (VAS, 0-100 mm). Second, we analysed ease of insertion, bleeding pattern, satisfaction, pregnancy, and expulsion rate. The follow-up time was 3 months.
The mean VAS score for nulliparous women was 74 mm (95% confidence interval, 95% CI 67-81) in the 'during menstruation' group, compared with 66 mm (95% CI 59-74) in the 'outside menstruation' group (P = 0.14). The mean VAS score for multiparous women was 30 mm (95% CI 20-40) in the 'during menstruation group', compared with 43 mm (95% CI 32-53) in the 'outside menstruation' group (P = 0.08). There was no difference between the stratified 'during menstruation' group and the 'outside menstruation' group with regards to ease of insertion, satisfaction, bleeding pattern, and median spotting and bleeding days for the use of the LNG-IUS 3 months after insertion.
As we did not find that the level of pain perceived during insertion was higher during menstruation, compared with outside menstruation, we conclude that the LNG-IUS can be inserted at any time during the menstrual cycle, especially in the case of nulliparous women.
We conducted an RCT on time of insertion of LNG-IUS. We conclude that the LNG-IUS can be inserted at any time.
评估患者在放置左炔诺孕酮宫内节育系统（LNG-IUS）时感知到的疼痛是否取决于月经周期的时间。
分层两臂非劣效性随机对照试验。
荷兰费尔德霍芬的一家大型教学医院。
2013 年 10 月至 2014 年 5 月，招募了 60 名未育和 60 名经产妇，将其随机分为两组，分别为“经期”（即月经第 1-7 天）或“经期外”（即月经结束后且无阴道出血期间的任意一天）组，比例为 1:1。8 名女性在随机分组后且放置前退出：因此，共收集并分析了 112 名女性的数据。
将女性随机分为“经期”（即月经第 1-7 天）或“经期外”（即月经结束后且无阴道出血期间的任意一天）组，比例为 1:1。
主要结局是通过视觉模拟量表（VAS，0-100mm）测量的放置过程中的疼痛程度。其次，我们分析了放置的难易程度、出血模式、满意度、妊娠和脱落率。随访时间为 3 个月。
在“经期”组中，未育女性的平均 VAS 评分为 74mm（95%置信区间 95%CI 67-81），而在“经期外”组中为 66mm（95%CI 59-74）（P=0.14）。在“经期”组中，经产妇的平均 VAS 评分为 30mm（95%CI 20-40），而在“经期外”组中为 43mm（95%CI 32-53）（P=0.08）。分层的“经期”组和“经期外”组在放置的难易程度、满意度、出血模式以及放置 LNG-IUS 3 个月后的中位点滴出血和出血天数方面均无差异。
由于我们未发现与经期相比，经期内放置时感知到的疼痛水平更高，因此我们得出结论，LNG-IUS 可以在月经周期的任何时间放置，尤其是在未育女性中。
我们进行了一项关于 LNG-IUS 放置时间的 RCT。我们的结论是，LNG-IUS 可以在任何时间放置。
