Comparison between 200 μg and 800 μg of vaginal misoprostol for cervical ripening before operative hysteroscopy: A randomized controlled trial

Abstract

Objective: To compare between 200 and 800 μg of vaginal misoprostol for cervical ripening before operative hysteroscopy. Methods: Quadruple-blind randomized clinical trial conducted between November 2019 and September 2020 involving 76 patients undergoing cervical dilatation before surgical hysteroscopy at teaching hospitals in Pernambuco, Brazil. Women received the vaginal misoprostol dosage of 200 or 800 μg,10–12 h before operative hysteroscopy. The cervical width was the primary outcome, and secondary outcomes were patient satisfaction, adverse effects, surgical complications, and duration of cervical dilatation. Chi-square tests of association, Fisher's exact and Mann–Whitney U tests were used with an α error of <5%. Results: There was no statistical difference between the groups in the mean of the cervical width (800 μg: 6.5 ± 1.6 mm vs 200 μg: 5.8 ± 1.8 mm, P = 0.055), patient satisfaction, and surgical findings, but the duration of cervical dilatation was lower in the 800-μg group (28.16 ± 28.5 s vs 41.97 ± 31.0 s, P = 0.035). Among the adverse effects, diarrhea was more frequent in the 800-μg group with statistical difference (100% vs 0%; P = 0.01). Conclusion: For cervical ripening, 200 μg misoprostol is equally effective with fewer adverse effects than 800 μg before operative hysteroscopy. ClinicalTrials.gov: NCT04152317. https://clinicaltrials.gov/ct2/show/NCT04152317.