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Comparison of self‐administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design *
Author(s) -
Oppegaard KS,
Nesheim BI,
Istre O,
Qvigstad E
Publication year - 2007
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/j.1471-0528.2007.01339.x
Subject(s) - medicine , misoprostol , placebo , visual analogue scale , hysteroscopy , evening , randomized controlled trial , obstetrics , anesthesia , cervix , surgery , pregnancy , abortion , genetics , alternative medicine , physics , pathology , cancer , astronomy , biology
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 (%).