A prospective, randomized, controlled trial comparing vaginal misoprostol and osmotic dilator in achieving cervical ripening before operative hysteroscopy Abstract The purpose of this study was to compare the effectiveness of vaginal misoprostol and an osmotic dilator in achieving cervical ripening before operative hysteroscopy in pre-menopausal women. One hundred patients undergoing operative hysteroscopies with a 9-mm hysteroscope were prospectively and randomly assigned to two groups. In group 1 (the misoprostol group), 53 patients received 400 μg of vaginal misoprostol 12 h before the operation. In group 2 (the osmotic dilator group), 47 patients had an osmotic dilator inserted into the cervical canal 12 h before the operation. The primary outcome measure in this study was cervical width, assessed by the largest number of Hegar dilators that could be inserted into the cervix without resistance. The secondary outcome measure was the subjective assessments of the ease of dilatation to 9 mm by the surgeon. Adverse effects experienced including preoperative pain and vaginal bleeding were recorded for each group. There was no difference between the two groups with regard to demographic variables. The spontaneous cervical dilatation (mean ± SD) in the osmotic dilator group (9.6±2.2 cm) was significantly (P<0.01) greater than that in the misoprostol group (8.0±1.8 cm). In addition, the proportion of difficult dilatation in the osmotic dilator group (8 out of 47, 17.0%) was significantly less than that in the misoprostol group (22 out of 53, 41.5%). The occurrence of vaginal bleeding in the misoprostol group (77.4%) was significantly (P<0.01) higher than that in the osmotic dilator group (31.9%). The osmotic dilator is more effective than misoprostol at achieving cervix ripening prior to operative hysteroscopy.