RETRACTED ARTICLE: Vaginal misoprostol before copper IUD insertion after previous insertion failure: a double-blind, placebo-controlled, parallel-group, randomised clinical trial

Abstract

Objective: The aim of the study was to assess whether vaginal administration of misoprostol before copper intrauterine device (IUD) insertion increased the success of the procedure among parous women with previous insertion failure.

Methods: A single-centre, parallel-group, double-blind, placebo-controlled, randomised clinical trial was conducted at Ain Shams University Maternity Hospital, Cairo, Egypt, between October 2015 and August 2016. The study comprised 90 parous women undergoing TCu380A IUD insertion after a failed attempt. A computer-generated list of random numbers was used to assign participants to receive either misoprostol 200 μg or a placebo tablet, applied vaginally 10 h and 4 h prior to the second attempted IUD insertion, without ultrasound guidance. The primary outcome was the success of IUD insertion. Secondary outcomes were to establish the effect on insertion success of cervical dilation, cervical softening and previous mode of delivery.

Results: Forty-two women (93.3%) in the misoprostol group and 24 women (53.3%) in the placebo group had a successful IUD insertion (p < .001). Cervical dilation was required in 24 women in the misoprostol group and 44 women in the placebo group. Misoprostol application significantly increased insertion success in women with previous caesarean delivery (p < .001) but did not affect insertion success in women with previous vaginal delivery (p = .481).

Conclusion: Vaginal misoprostol before IUD insertion in parous women with previous insertion failure increased the rate of successful insertion, particularly in women with previous caesarean delivery.

Trial registration: ClinicalTrials.gov identifier: NCT03790371.

摘要

目的：该研究的目的是评估含铜宫内节育器 (IUD) 置入前阴道应用米索前列醇是否能提高既往置入失败产妇的手术成功率。

方法:2015年10月至2016年8月, 在埃及开罗的Ain Shams大学妇产医院进行了单中心、平行组、双盲、安慰剂对照的随机临床试验。这项研究包括90名在失败的尝试后接受TCu380A IUD置入术的产妇。计算机生成的随机数字列表用于指定参与者接受米索前列醇200 µg或安慰剂片剂, 在第二次尝试放置IUD之前10小时和4小时应用, 无需超声引导。主要结果是IUD放置成功。次要结果是确定宫颈扩张、宫颈软化和先前分娩方式对置入成功率的影响。

结果：米索前列醇组42名妇女 (93.3%) 和安慰剂组24名妇女 (53.3%) 成功置入IUD (P < 0.001)。米索前列醇组24名妇女和安慰剂组44名妇女需要宫颈扩张。米索前列醇的应用显著增加了既往剖腹产妇女的置入成功率 (p < 0.001), 但对既往阴道分娩妇女的置入成功率没有影响 (p =0.481)。

结论：对既往置入失败的产妇, 在IUD置入术前阴道应用米索前列醇, 可提高置入成功率, 特别是对既往有剖宫产史的产妇。

Keywords:

• Copper intrauterine device
• insertion failure
• intrauterine contraception
• misoprostol

View retraction statement:

Retraction Notice

Disclosure statement

No potential conflict of interest was reported by the authors.