Study Objective

To compare the effectiveness of misoprostol and dinoprostone tablets administered vaginally 3 hours before copper intrauterine device (IUD) insertion vs placebo in reducing pain and increasing ease of insertion among nulliparous women.

Design

Randomized controlled trial.

Setting

Tertiary referral hospital.

Participants

A total of 129 nulliparous women requesting a Copper T380A IUD insertion.

Interventions

Women were randomized to receive 200 μg misoprostol or 3 mg dinoprostone or placebo 3 hours before IUD insertion.

Main Outcome Measure(s)

Primary outcome was patient-reported pain during IUD insertion using a 10-cm visual analog scale (VAS). Secondary outcomes include provider ease of insertion, women satisfaction level, and side effects.

Results

Participants' baseline characteristics were comparable between the study groups. Mean pain score during IUD insertion was lower with misoprostol than placebo (3.1 ± 2.3 vs 4.4 ± 2.2; P = .02) and dinoprostone compared to placebo (2.4 ± 1.8 vs 4.4 ± 2.2; P < .001). Clinicians reported easier IUD insertion with misoprostol than placebo (2.4 ± 1.7 vs 4.0 ± 2.4; P = .001) and dinoprostone compared to placebo (2.0 ± 1.5 vs 4.0 ± 2.4; P < .001). Women's satisfaction levels were higher with both misoprostol and dinoprostone than placebo (P < .001). Side effects did not differ among the 3 study groups.

Conclusions

Premedication with vaginal misoprostol or dinoprostone effectively lowered pain during copper IUD insertion. However, the reduction in pain scores was clinically significant only in women who received dinoprostone. In both the misoprostol and dinoprostone groups, clinicians found the procedure easier, and women were more satisfied with IUD insertion. Side effects and complications were similar in all groups.

中文翻译：

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阴道Misoprostol与阴道Dinoprostone的比较功效在无卵妇女插入铜T380A宫内节育器之前3小时进行：随机对照试验。

研究目标

为了比较米索前列醇和狄诺前列酮片在宫腔内铜缆插入术前（IUD）与安慰剂相比在阴道内给药3小时的效果，以减轻疼痛和增加未产妇的插入率。

设计

随机对照试验。

设置

三级转诊医院。

参加者

共有129例未婚妇女要求插入铜T380A IUD。

干预措施

妇女在插入宫内节育器前3小时随机分组接受200μg米索前列醇或3 mg地诺前列酮或安慰剂。

主要观察指标）

主要结局是使用10厘米视觉模拟评分表（VAS）在IUD插入过程中患者报告的疼痛。次要结果包括提供者的插入容易程度，女性满意度和副作用。

结果

研究组之间参与者的基线特征相当。米索前列醇在宫内节育器插入期间的平均疼痛评分低于安慰剂组（3.1±2.3 vs 4.4±2.2；P  = .02）和地诺前列酮低于安慰剂组（2.4±1.8 vs 4.4±2.2；P  <.001）。临床医生报告说，米索前列醇比安慰剂（2.4±1.7 vs 4.0±2.4；P  = .001）和狄诺前列酮比安慰剂（2.0±1.5 vs 4.0±2.4；P  <.001）更容易插入宫内节育器。米索前列醇和地诺前列酮对女性的满意度均高于安慰剂组（P  <.001）。3个研究组之间的副作用没有差异。

结论

阴道米索前列醇或地诺前列酮的预用药可有效减轻铜制宫内节育器插入过程中的疼痛。但是，疼痛分数的降低仅在接受狄诺前列酮的女性中具有临床意义。在米索前列醇和地诺前列酮组中，临床医生都发现该过程更容易，并且妇女对宫内节育器的插入更加满意。所有组的副作用和并发症均相似。