Comparative Efficacy of Vaginal Misoprostol vs Vaginal Dinoprostone Administered 3 Hours Prior to Copper T380A Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial.

Abstract

To compare the effectiveness of misoprostol and dinoprostone tablets administered vaginally 3hours before copper intrauterine device (IUD) insertion vs placebo in reducing pain and increasing ease of insertion among nulliparous women. Randomized controlled trial. Tertiary referral hospital. A total of 129 nulliparous women requesting a Copper T380A IUD insertion. Women were randomized to receive 200μg misoprostol or 3mg dinoprostone or placebo 3hours before IUD insertion. Primary outcome was patient-reported pain during IUD insertion using a 10-cm visual analog scale (VAS). Secondary outcomes include provider ease of insertion, women satisfaction level, and side effects. Participants' baseline characteristics were comparable between the study groups. Mean pain score during IUD insertion was lower with misoprostol than placebo (3.1±2.3 vs 4.4±2.2; P=.02) and dinoprostone compared to placebo (2.4±1.8 vs 4.4±2.2; P<.001). Clinicians reported easier IUD insertion with misoprostol than placebo (2.4±1.7 vs 4.0±2.4; P=.001) and dinoprostone compared to placebo (2.0±1.5 vs 4.0±2.4; P<.001). Women's satisfaction levels were higher with both misoprostol and dinoprostone than placebo (P<.001). Side effects did not differ among the 3 study groups. Premedication with vaginal misoprostol or dinoprostone effectively lowered pain during copper IUD insertion. However, the reduction in pain scores was clinically significant only in women who received dinoprostone. In both the misoprostol and dinoprostone groups, clinicians found the procedure easier, and women were more satisfied with IUD insertion. Side effects and complications were similar in all groups.