STUDY OBJECTIVE: To compare results of diagnostic hysteroscopy in postmenopausal women using misoprostol for cervical ripening. DESIGN: A randomized, placebo-controlled clinical trial (Canadian Task Force classification Ib). SETTING: Hospital Barão de Lucena, Instituto Materno Infantil de Pernambuco. PATIENTS: One hundred-twenty postmenopausal women. INTERVENTION: Postmenopausal women received 200 microg of vaginal misoprostol or placebo before hysteroscopy. MEASUREMENTS AND MAIN RESULTS: Variables measured were procedure time, frequency of hysteroscopy carried out in each group (misoprostol and placebo), degree of pain during procedure, need for dilation, side effects, and complications of hysteroscopy. The chi2, Fisher's exact, and Mann-Whitney tests were used and considered significant when alpha error was <5%. There were similarities between the groups in age (p = .09), body mass index (p = .55), time since menopause (p = .52), and genital bleeding (p = .52). Pain during the procedure, as measured by visual analog scale, was less severe in the misoprostol group than in the placebo group (median of 05 vs 07, p = .02), but there were similarities in duration (2.4 min vs 2.0 min, p = .3), pain during procedure and biopsy (p = .74 vs p = .19), need for dilation (p = .66), side effects, and complications. There were no differences in severity of post-procedure pain. CONCLUSIONS: Previous use of misoprostol reduced pain severity during hysteroscopy.
RCT Entities:
STUDY OBJECTIVE: To compare results of diagnostic hysteroscopy in postmenopausal women using misoprostol for cervical ripening. DESIGN: A randomized, placebo-controlled clinical trial (Canadian Task Force classification Ib). SETTING: Hospital Barão de Lucena, Instituto Materno Infantil de Pernambuco. PATIENTS: One hundred-twenty postmenopausal women. INTERVENTION: Postmenopausal women received 200 microg of vaginal misoprostol or placebo before hysteroscopy. MEASUREMENTS AND MAIN RESULTS: Variables measured were procedure time, frequency of hysteroscopy carried out in each group (misoprostol and placebo), degree of pain during procedure, need for dilation, side effects, and complications of hysteroscopy. The chi2, Fisher's exact, and Mann-Whitney tests were used and considered significant when alpha error was <5%. There were similarities between the groups in age (p = .09), body mass index (p = .55), time since menopause (p = .52), and genital bleeding (p = .52). Pain during the procedure, as measured by visual analog scale, was less severe in the misoprostol group than in the placebo group (median of 05 vs 07, p = .02), but there were similarities in duration (2.4 min vs 2.0 min, p = .3), pain during procedure and biopsy (p = .74 vs p = .19), need for dilation (p = .66), side effects, and complications. There were no differences in severity of post-procedure pain. CONCLUSIONS: Previous use of misoprostol reduced pain severity during hysteroscopy.