Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR 97239, USA.
Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.
This study was conducted to examine the effects of prophylactic misoprostol prior to intrauterine device (IUD) placement in nulliparous women.
Nulliparous, reproductive-aged women desiring an IUD for contraception were randomized to receive 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. Subjects completed a series of 100-mm visual analogue scales (VAS, anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain at several times points (anticipated pain, leg positioning, speculum placement, tenaculum placement, IUD insertion, equipment removal and 5 min postinsertion). Secondary outcomes included provider "ease of placement" (100-mm VAS, anchors: 0=easy, 100 mm=extremely difficult), side effects and retention of the IUD after 1 month (self-report or clinic visit). The study had 80% power (α=0.05, one-sided) to detect a reduction with treatment of 20 mm in VAS scores with a combined sample size of 34.
A total of 40 subjects were randomized to receive either misoprostol or placebo, and 35 completed the study. Five subjects withdrew (four prior to receiving study medication and one declined IUD). Baseline characteristics were similar between groups. There were no significant differences in patient-reported pain with IUD placement [misoprostol 65 mm (SD 21), placebo 55 mm (SD 21), p=.83] or at any other time point. Moreover, the misoprostol group reported significantly more preinsertion nausea (29% vs. 5%, p=.05) and cramping (47% vs. 16%, p=.04) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported.
Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects.
本研究旨在探讨在未产妇中放置宫内节育器（IUD）前使用米索前列醇预防的效果。
希望使用 IUD 避孕的未产妇被随机分为两组，分别在放置 IUD 前 90 分钟接受 400 mcg 颊部米索前列醇或安慰剂。受试者在多个时间点（预期疼痛、腿部定位、窥器放置、钳子放置、IUD 插入、设备移除和插入后 5 分钟）使用 100 毫米视觉模拟量表（VAS，锚定：0=无，100 毫米=最可想象的最差）来测量他们的感知疼痛。次要结局包括提供者“放置容易度”（100 毫米 VAS，锚定：0=容易，100 毫米=非常困难）、副作用和 1 个月后 IUD 的保留情况（自我报告或就诊）。该研究具有 80%的效能（α=0.05，单侧），以检测治疗组 VAS 评分降低 20 毫米，样本量为 34 例。
共 40 名受试者被随机分配接受米索前列醇或安慰剂，35 名受试者完成了研究。5 名受试者退出（4 名在接受研究药物之前，1 名拒绝 IUD）。基线特征在两组之间相似。在 IUD 放置时患者报告的疼痛[米索前列醇 65 毫米（SD 21），安慰剂 55 毫米（SD 21），p=0.83]或其他任何时间点均无显著差异。此外，米索前列醇组报告的插入前恶心（29%比 5%，p=0.05）和痉挛（47%比 16%，p=0.04）明显多于安慰剂组。虽然提供者报告的插入容易度在两组之间没有显著差异，但 3 名安慰剂患者需要额外扩张，而米索前列醇组没有。所有 35 名受试者均在插入后至少 1 个月进行了随访，未报告脱落。
在未产妇中放置 IUD 前使用米索前列醇预防并不能减轻患者的感知疼痛，但似乎增加了插入前的副作用。
