RANDOMIZED CONTROLLED TRIAL
Cervical ripening using vaginal misoprostol before hysteroscopy: a double-blind randomized trial.
Journal of Minimally Invasive Gynecology 2008 November
STUDY OBJECTIVE: The aim of this study was to evaluate the use of vaginal misoprostol to decrease both the force required to dilate the cervix and the pain experienced during a hysteroscopy.
DESIGN: Randomized clinical trial (RCT) (Canadian Task Force classification I).
SETTING: University hospital gynecology clinic.
PATIENTS: A total of 101 patients needing a diagnostic hysteroscopy. Fifty patients were randomized to the misoprostol group and 51 to the placebo group. Patient characteristics were similar in the 2 groups.
INTERVENTIONS: Self-administration of 400 microg of vaginal misoprostol or vaginal placebo 12 to 24 hours before a hysteroscopy.
MEASUREMENTS AND MAIN RESULTS: The force needed to dilate the cervix was assessed by a tonometer, and pain was measured by a visual analog scale. The force to dilate the cervix to 6mm was significantly less in the misoprostol group (5.0 vs 7.5N, p=.02). Pain-related measurements after dilatation of the cervix to 6mm were significantly reduced in the misoprostol group (42.1 vs 57.2, p=.004). The main side effect reported with the use of the drug was pelvic cramping.
CONCLUSION: The use of 400 microg of vaginal misoprostol 12 to 24 hours before hysteroscopy reduces the pain and the force needed to dilate the cervix, with only mild side effects.
DESIGN: Randomized clinical trial (RCT) (Canadian Task Force classification I).
SETTING: University hospital gynecology clinic.
PATIENTS: A total of 101 patients needing a diagnostic hysteroscopy. Fifty patients were randomized to the misoprostol group and 51 to the placebo group. Patient characteristics were similar in the 2 groups.
INTERVENTIONS: Self-administration of 400 microg of vaginal misoprostol or vaginal placebo 12 to 24 hours before a hysteroscopy.
MEASUREMENTS AND MAIN RESULTS: The force needed to dilate the cervix was assessed by a tonometer, and pain was measured by a visual analog scale. The force to dilate the cervix to 6mm was significantly less in the misoprostol group (5.0 vs 7.5N, p=.02). Pain-related measurements after dilatation of the cervix to 6mm were significantly reduced in the misoprostol group (42.1 vs 57.2, p=.004). The main side effect reported with the use of the drug was pelvic cramping.
CONCLUSION: The use of 400 microg of vaginal misoprostol 12 to 24 hours before hysteroscopy reduces the pain and the force needed to dilate the cervix, with only mild side effects.
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