OBJECTIVE: To compare the effectiveness of oral and vaginal misoprostol for preoperative cervical ripening in premenopausal women before hysteroscopic surgery. DESIGN:Placebo-controlled, double blind, randomized trial. SETTING:University hospital. PATIENT(S): Eighty-six premenopausal women eligible for operative hysteroscopy were recruited. Nine women were excluded from the study. INTERVENTION(S): Patients were randomly assigned to receive 400 microg of misoprostol orally (n = 39) or vaginally (n = 38), 10-12 hours before operative hysteroscopy. MAIN OUTCOME MEASURE(S): Extent of initial cervical width, percentage of patients requiring cervical dilatation, duration of cervical dilatation and surgical procedure, complications during procedure, and associated side effects. RESULT(S): Mean cervical widths in the vaginal and oral misoprostol groups after treatment were 7.3 +/- 1.6 mm and 6.0 +/- 1.5 mm, respectively, which was a statistically significant difference. Time required for cervical dilatation (98.6 +/- 88.7 s vs. 49.1 +/- 34.9 s) and duration of surgery (14.5 +/- 6 vs. 7.7 +/- 4.0 min) was statistically significantly shorter in the vaginal misoprostol group. The percentage of women with an initial cervical width of 9 mm was statistically significantly higher in the vaginal misoprostol group (36.8% vs. 5.1%). Uterine perforation occurred in two patients in the oral misoprostol group and in none in the vaginal misoprostol group. Side effects were comparable between the two treatment groups. CONCLUSION(S): Vaginal administration of misoprostol is more effective than the oral route for preoperative cervical ripening in premenopausal women.
RCT Entities:
OBJECTIVE: To compare the effectiveness of oral and vaginal misoprostol for preoperative cervical ripening in premenopausal women before hysteroscopic surgery. DESIGN: Placebo-controlled, double blind, randomized trial. SETTING: University hospital. PATIENT(S): Eighty-six premenopausal women eligible for operative hysteroscopy were recruited. Nine women were excluded from the study. INTERVENTION(S): Patients were randomly assigned to receive 400 microg of misoprostol orally (n = 39) or vaginally (n = 38), 10-12 hours before operative hysteroscopy. MAIN OUTCOME MEASURE(S): Extent of initial cervical width, percentage of patients requiring cervical dilatation, duration of cervical dilatation and surgical procedure, complications during procedure, and associated side effects. RESULT(S): Mean cervical widths in the vaginal and oral misoprostol groups after treatment were 7.3 +/- 1.6 mm and 6.0 +/- 1.5 mm, respectively, which was a statistically significant difference. Time required for cervical dilatation (98.6 +/- 88.7 s vs. 49.1 +/- 34.9 s) and duration of surgery (14.5 +/- 6 vs. 7.7 +/- 4.0 min) was statistically significantly shorter in the vaginal misoprostol group. The percentage of women with an initial cervical width of 9 mm was statistically significantly higher in the vaginal misoprostol group (36.8% vs. 5.1%). Uterine perforation occurred in two patients in the oral misoprostol group and in none in the vaginal misoprostol group. Side effects were comparable between the two treatment groups. CONCLUSION(S): Vaginal administration of misoprostol is more effective than the oral route for preoperative cervical ripening in premenopausal women.
Authors: David K Turok; Eve Espey; Alison B Edelman; Pamela S Lotke; Eva H Lathrop; Stephanie B Teal; Janet C Jacobson; Sara E Simonsen; Kenneth F Schulz Journal: Trials Date: 2011-04-29 Impact factor: 2.279