OBJECTIVE(S) To assess efficacy and safety of self-administered 3 mg dinoprostone vaginally in reducing pain during copper intrauterine device (IUD) insertion in parous women. DESIGN Randomized, double-blinded, placebo-controlled trial. SETTING Family planning clinic in a tertiary referral hospital. PATIENT(S) Multiparous women who were attending a family planning clinic and requesting copper IUD insertion. INTERVENTIONS(S) We randomly assigned 160 participants into two groups: The dinoprostone group (n = 80) received 3 mg dinoprostone vaginally, and the placebo group (n = 80) received placebo vaginally. MAIN OUTCOME MEASURE(S) Our primary outcome was mean pain scores during IUD insertion. Our secondary outcomes were mean pain scores during tenaculum application, during uterine sounding, and 15 minutes after insertion, ease of insertion, satisfaction score, need for additional analgesics, and side-effects. RESULT(S) Both groups showed no significant difference in anticipated pain score (P=.41), pain during tenaculum placement (P=.22), and pain during sound insertion (P=.07). The dinoprostone group had significantly lower pain scores during IUD insertion (34.8 ± 10.1 vs. 57.8 ± 11.8) and 15 minutes after insertion (20.6 ± 6.4 vs. 29.6 ± 6.2), easier IUD insertion (43.6 ± 21.9 vs. 64.7 ± 18.1), and higher satisfaction (83.9 ± 11.6 vs. 63.0 ± 9.1) compared with the placebo group. Fewer patients required additional analgesics in the dinoprostone group compared with the placebo group (P=.01). Side-effects were similar between the groups. CONCLUSION(S) Self-administered 3 mg dinoprostone vaginally before copper IUD insertion in parous women reduces pain scores during IUD insertion, making insertion easier and increasing women's satisfaction, with tolerable side-effects. CLINICAL TRIAL REGISTRATION NUMBER NCT04046302.

中文翻译：

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自我给药阴道地诺前列酮对经产妇女置入铜宫内节育器时痛觉的影响：一项随机对照试验

目的（S）评估经阴道自我给药 3 mg 地诺前列酮在减轻经产妇女插入铜宫内节育器（IUD）期间的疼痛的有效性和安全性。设计 随机、双盲、安慰剂对照试验。设置在三级转诊医院的计划生育诊所。患者 正在计划生育诊所就诊并要求插入带铜宫内节育器的经产妇。干预措施 我们将 160 名参与者随机分为两组：地诺前列酮组（n = 80）阴道接受 3 mg 地诺前列酮，安慰剂组（n = 80）阴道接受安慰剂。主要结果测量我们的主要结果是放置宫内节育器期间的平均疼痛评分。我们的次要结果是使用持钩期间、子宫探查期间和插入后 15 分钟的平均疼痛评分、插入的难易程度、满意度评分、对额外镇痛药的需求和副作用。结果（S） 两组在预期疼痛评分（P=.41）、握柄放置时的疼痛（P=.22）和声音插入时的疼痛（P=.07）方面没有显着差异。地诺前列酮组在放置宫内节育器期间（34.8 ± 10.1 vs. 57.8 ± 11.8）和放置后 15 分钟（20.6 ± 6.4 vs. 29.6 ± 6.2）的疼痛评分显着降低，更容易放置宫内节育器（43.6 ± 21.9 vs. 64.7）± 18 ，与安慰剂组相比，满意度更高（83.9 ± 11.6 vs. 63.0 ± 9.1）。与安慰剂组相比，地诺前列酮组中需要额外镇痛药的患者更少（P=0.01）。各组之间的副作用相似。结论 (S) 经产妇女在放置带铜宫内节育器之前阴道自我给药 3 mg 地诺前列酮可降低宫内节育器放置期间的疼痛评分，使插入更容易并提高女性的满意度，同时具有可以容忍的副作用。临床试验注册号 NCT04046302。