Effect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCT
Effect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCT
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DOI：
10.1093/humrep/dev137
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发表时间：
2015-08-01
影响因子：
6.1
通讯作者：
Bahamondes, Luis
中科院分区：
文献类型：
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作者：
Bahamondes, M. Valeria;Espejo-Arce, Ximena;Bahamondes, Luis
研究问题：米索前列醇预处理对首次放置宫内避孕药失败后放置宫内避孕药（IUCs）是否有用？摘要回答：在IUC置入失败后第二次放置IUC前10和4小时阴道内给予200 mcg米索前列醇预处理在促进IUC置入方面明显优于安慰剂。已知：IUC使用率低的原因之一是插入困难的概念。在几项随机临床试验（RCT）中，在插入IUC前使用米索前列醇以促进插入。总体而言，与安慰剂相比，结果无显著差异。然而，大多数先前的研究都是在女性中进行的，而本研究是在先前插入failure.study设计，尺寸，持续时间的女性中进行的：这是一项在2013年2月至2014年10月期间进行的双盲RCT。参与者是104名要求插入IUC的女性，第一次尝试插入失败。在插入失败后，这些妇女收到一个装有米索前列醇或安慰剂的密封信封。一个区组大小的随机化系统（1：1）是计算机生成的。参与者/材料，设置，方法：该研究在三级护理中心进行。在女性返回诊所进行新的插入尝试前10和4小时，指导女性阴道插入一片米索前列醇200 mg（Prostokos，Hebron，Cariacica，PE，Brazil）或安慰剂。结果是成功插入IUC和插入程序前立即使用宫颈扩张器。主要结果和机会的作用：在研究期间，共有2639名妇女要求插入IUC。在2535名女性（96%）中首次尝试插入IUC，104名我们无法插入器械的女性有资格参加RCT。4名妇女拒绝，100名妇女被随机分配（55名为米索前列醇组，45名为安慰剂组）。米索前列醇组和安慰剂组分别有55例和37例妇女选择左炔诺孕酮宫内缓释系统（LNG-IUS），无妇女选择TCu 380 A宫内节育器（Cu-IUD），8例妇女选择安慰剂组。分别分配到米索前列醇组和安慰剂组的7名和3名妇女在随机分组后从未返回诊所。我们分别对48名女性中的42名（87.5%）和42名随机接受米索前列醇和安慰剂的女性中的26名（61.9%）进行了IUC（P = 0.0066）。关于可评价人群，成功插入的相对风险（RR）为1.41（绝对差异的95%置信区间（CI）为8.2，43.0），P = 0.0066）;意向治疗人群的RR（95% CI）为1.32（0.3，36.9）。多元回归分析显示，与插入失败相关的显著变量是剖宫产次数>= 1（P = 0.020）和使用安慰剂（P = 0.026）。21例使用扩张器随机分配至米索前列醇组和安慰剂组的48名妇女中有43.7%（48/42）和21名（50%）（P = 0.804）.局限性，谨慎的原因：局限性是大多数妇女选择LNG-IUS，因此Cu-IUD的数据有限，研究结果的更广泛意义：结果表明IUC插入困难和失败并不常见。阴道内米索前列醇预处理有助于首次尝试插入失败后的IUC插入，插入失败与剖腹产次数相关。
STUDY QUESTION: Is pretreatment with misoprostol useful in insertion of intrauterine contraceptives (IUCs) after insertion failure at the first attempt?summary answer: Pretreatment with intravaginal administration of 200 mcg of misoprostol after IUC insertion failure 10 and 4 h before the second attempt of IUC placement was significantly better than placebo at facilitating the insertion of an IUC.what is known already: One of the reasons for low use of IUCs is the concept that insertion is difficult. Misoprostol was used in several randomized clinical trials (RCT) before IUC insertion to facilitate the insertion. In general, the results showed no significant differences when compared with placebo. However, most previous studies have been carried out among unselected women whereas the present study is among women with previous insertion failure.study design, size, duration: This was a double blind RCT conducted between February 2013 and October 2014. Participants were 104 women who requested an insertion of an IUC and the insertion failed at the first attempt. After insertion failure, the women received a sealed envelope with misoprostol or placebo. The randomization system (1: 1) in one block size was computer-generated.participants/materials, setting, methods: The study was conducted at a tertiary care centre. The women were instructed to insert vaginally one tablet of misoprostol 200 mg (Prostokos, Hebron, Cariacica, PE, Brazil) or placebo 10 and 4 h before the woman returned to the clinic for a new insertion attempt. The outcomes were successful IUC insertion and the use of a cervical dilator immediately prior to the insertion procedure.main results and the role of chance: A total of 2639 women requested the insertion of an IUC during the study period. The IUC was inserted at the first attempt in 2535 women (96%) and 104 women in whom we were unable to insert the device were eligible to participate in the RCT. Four women declined and 100 women were randomized (55 for the misoprostol group and 45 for the placebo group). From the 100 participating women, the levonorgestrel-releasing intrauterine system (LNG-IUS) was chosen by 55 and 37 women and the TCu380A intrauterine device (Cu-IUD) was chosen by none and 8 women in the misoprostol and placebo group, respectively. Seven and three women allocated to misoprostol and placebo, respectively, never returned to the clinic after randomization. We placed the IUC in 42 (87.5%) out of the 48 women and in 26 (61.9%) out of the 42 women randomized to misoprostol and placebo, respectively (P = 0.0066). Regarding the Evaluable Population the relative risk (RR) of successful insertions was 1.41 (95% confidence interval (CI) for absolute difference (8.2, 43.0), P = 0.0066); in the Intent-to-Treat Population the RR (95% CI) was 1.32 (0.3, 36.9). Multiple regression analysis showed that the significant variables associated with the insertion failure were the number of Caesarean section >= 1 (P = 0.020) and the use of placebo (P = 0.026). Dilators were used in 21 (43.7%) out of the 48 and 21 (50%) out of the 42 women randomized to misoprostol and placebo, respectively (P = 0.804).limitations, reasons for caution: The limitations were that the majority of the women chose the LNG-IUS, and consequently the data for the Cu-IUD were limited, and there was a small number of nulligravidas.wider implications of the findings: The results show that IUC insertion difficulties and failures are not common. Pretreatment with intravaginal misoprostol facilitated IUC insertion after failure of insertion at the first attempt, and insertion failure was associated with number of Caesarean sections.