Self-administered

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Trade Name: Cytotec Product Name: Cytotec Product Code: misoprostol Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Vaginal use CONDITION: Intrauterine pathology PRIMARY OUTCOME: Main Objective: To investigate ; the effectiveness of vaginal misoprostol on ; cervical priming measured as "the largest size of ; Hegar dilator (mm) inserted without resistance" ; prior to hysteroscopy in non‐pregnant, ; pre‐menopausal and post‐menopausal women. ; Null‐hypothesis: there is no clinically ; significant difference in pre‐operative baseline ; cervical dilatation (<1mm), between women who ; receive misoprostol and women who receive ; placebo. Primary end point(s): Pre‐operative ; baseline cervical dilatation (mm) in the two ; treatment groups. Secondary Objective: The number ; of women who achieve satisfactory cervical ; priming (cervical dilatation > = 5 mm). Number ; of dilatations judged as "easy" or "difficult". ; Frequency of complications. Acceptability of ; self‐administration of vaginal capsules at ; home. INCLUSION CRITERIA: All patients who are referred to outpatient hysteroscopy and who have given informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 199886dbc96aa97780997036c158b745f767f30b
First added on: Jul 27, 2021