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document
Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design . OBJECTIVE To compare the impact of 1000-microgram self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women prior to outpatient resectoscopy . DESIGN Randomised , double-blind , placebo-controlled sequential trial . SETTING Norwegian university teaching hospital . SAMPLE Premenopausal and postmenopausal women referred to outpatient resectoscopy . METHODS The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient resectoscopy . MAIN OUTCOME MEASURES Preoperative cervical dilatation , acceptability and complications . RESULTS ( a ) Intraoperative findings and distribution of cervical dilatation in the two treatment groups . Values are given as median ( range ) or n ( % ) . ( b ) Acceptability in the two treatment groups . Values are given as completely acceptable , n ( % ) ; fairly acceptable , n ( % ) ; fairly unacceptable , n ( % ) and completely unacceptable , n ( % ) . ( c ) Pain in the two treatment groups . Pain was measured with a visual analogue scale score , scale ranges from 0 ( no pain ) to 10 ( unbearable pain ) . Values are given as median ( range ) . ( d ) Occurrence of adverse effects in the two treatment groups . Values are given as n ( % ) . ( e ) Complications , given as n ( % ) .
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Intervention_Pharmacological
self-administered vaginal misoprostol
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Intervention_Control
placebo
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Intervention_Pharmacological
self-administered vaginal misoprostol
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Intervention_Control
self-administered vaginal placebo
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Intervention_Pharmacological
self-administered vaginal misoprostol
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Intervention_Control
self-administered vaginal placebo
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Outcome_Physical
Preoperative cervical dilatation
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Outcome_Other
acceptability
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Outcome_Adverse-effects
complications
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Outcome_Other
Acceptability
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Outcome_Pain
Pain
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Outcome_Pain
Pain
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Outcome_Adverse-effects
Occurrence of adverse effects
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Outcome_Adverse-effects
Complications
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Participant_Condition
premenopausal and postmenopausal
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Participant_Sex
women
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Participant_Condition
outpatient resectoscopy
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Participant_Condition
Premenopausal and postmenopausal
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Participant_Sex
women
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Participant_Condition
outpatient resectoscopy