Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized, double blind, placebo-controlled trial.

Objective: To evaluate the effectiveness of sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women.

Design: Placebo-controlled, double-blind, randomized trial.

Setting: University hospital.

Patient(s): Fifty-two women with an indication for diagnostic hysteroscopy.

Intervention(s): Randomized women who had received either 200 mug of misoprostol (n = 25) or placebo (n = 27) sublingually 2 hours before hysteroscopy. Two subgroups (women with or without previous vaginal delivery) were formed.

Main Outcome Measure(s): Number of women requiring cervical dilatation, duration of dilatation, ease of dilatation, and complications during procedure.

Result(s): In the misoprostol group, 14 patients needed cervical dilatation, versus 21 in the placebo group. Duration of dilatation was longer in the placebo group than in the misoprostol group. In subgroup 1, seven patients in the misoprostol group (n = 13) and nine patients in the placebo group (n = 12) needed cervical dilatation. The duration of the dilatation was similar between the groups. In subgroup 2, both the need for cervical dilatation (58.3% vs. 80.0%) and the duration of dilatation (31.0 +/- 18.8 vs. 73.0 +/- 82.0 seconds) were found to be lower in the misoprostol (n = 15) than in the placebo (n = 12) group, respectively. Those differences were all not significant.

Conclusion(s): Sublingual misoprostol before diagnostic hysteroscopy did not seem to facilitate cervical ripening statistically; however, the results are remarkable and are promising clinically. Further studies are required to reassess the use of sublingual misoprostol in patients before hysteroscopy.