RETRACTED ARTICLE: Vaginal misoprostol before copper IUD insertion after previous insertion failure: a double-blind, placebo-controlled, parallel-group, randomised clinical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