RANDOMIZED CONTROLLED TRIAL
Cervical ripening before operative hysteroscopy in premenopausal women: a randomized, double-blind, placebo-controlled comparison of vaginal and oral misoprostol.
Fertility and Sterility 2008 April
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.
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.
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