Study Objective

To assess safety and efficacy of self-administered vaginal dinoprostone 12 hours before a 52-mg levonorgestrel intrauterine device (LNG-IUD) insertion in adolescents and young nulliparous women.

Design

Randomized controlled trial.

Setting

Tertiary referral hospital.

Participants

Nulliparous adolescents and young women aged 18-22 years.

Interventions

Participants were randomly assigned into 2 groups; the dinoprostone group (n = 65) received dinoprostone 3 mg vaginally, and the placebo group (n = 65) received placebo tablets vaginally.

Main Outcome Measures

Primary outcome was pain scores during LNG-IUD insertion measured using a visual analogue scale. Secondary outcomes were pain scores during speculum insertion, tenaculum placement, uterine sounding, and 20 minutes postprocedure, ease of insertion, Women's satisfaction score, need for additional analgesics, and side effects.

Results

The dinoprostone group had significantly lower pain scores during LNG-IUD insertion (2.83 ± 1.08 vs 3.95 ± 1.63), tenaculum placement (2.97 ± 1.41 vs 4.55 ± 1.53) and sounding of uterus (3.55 ± 1.71 vs 5.12 ± 1.37) compared with the placebo group (P < .001). No significant differences were found between both groups regarding anticipated pain scores (P = .85), pain during speculum insertion and 20 minutes postinsertion and insertion duration (P = .53). Women's satisfaction, provider reported ease of insertion, and need for additional analgesia were significantly better among dinoprostone users (P < .001, < .001, and .02, respectively). Side effects and procedure complications were similar for the 2 groups.

Conclusion

Self-administered dinoprostone 3 mg vaginally 12 hours before a 52-mg LNG-IUD insertion in nulliparous adolescent and young women effectively reduced pain during insertion and increased women's satisfaction and ease of insertion reported by clinicians.

中文翻译：

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左炔诺孕酮在宫内节育器和年轻妇女中放开左炔诺孕酮宫内节育器前12小时自行服用阴道Dinoprostone的益处：随机对照试验。

研究目标

评估在52 mg左炔诺孕酮宫内节育器（LNG-IUD）插入青少年和未生育的年轻妇女前12小时自我给药的阴道地诺前列酮的安全性和疗效。

设计

随机对照试验。

设置

三级转诊医院。

参加者

18至22岁的未婚青少年和年轻妇女。

干预措施

参加者随机分为2组。地诺前列酮组（n = 65）阴道接受3 mg地诺前列酮，而安慰剂组（n = 65）阴道接受安慰剂片。

主要观察指标

主要结果是使用视觉模拟量表测量LNG-IUD插入过程中的疼痛评分。次要结果是在窥镜插入期间的疼痛评分，触角放置，子宫探空术和术后20分钟，插入容易度，女性满意度评分，是否需要额外的镇痛药以及副作用。

结果

与LNG-IUD插入相比，狄诺前列酮组在LNG-IUD插入过程中的疼痛评分（2.83±1.08 vs 3.95±1.63），触角位置（2.97±1.41 vs 4.55±1.53）和子宫听起来明显更低（3.55±1.71 vs 5.12±1.37）。安慰剂组（P  <.001）。两组之间在预期的疼痛评分（P  = .85），窥镜插入以及插入后20分钟和插入持续时间的疼痛（P  = .53）方面均没有发现显着差异。妇女的满意度，提供者报告的易于插入以及使用地诺前列酮的患者对其他镇痛的需求明显更好（分别为P  <.001，<.001和.02）。两组的副作用和手术并发症相似。

结论

在52毫克LNG-IUD插入之前，阴道未使用的青春期和年轻妇女在3毫克阴道给药前12个小时自我给药的地诺前列酮有效减轻了插入过程中的疼痛，并增加了临床医生报告的妇女满意度和插入便利性。