Self-administered vaginal misoprostol at home for cervical ripening prior to outpatient hysteroscopy: a randomised placebo-controlled trial. - Hysteroscopy and misoprostol project
Phase 1
- Conditions
- Intrauterine pathology
- Registration Number
- EUCTR2006-001201-28-NO
- Lead Sponsor
- Department of Gynaecology, Helse Finnmark, Klinikk Hammerfest
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Female
- Target Recruitment
- 200
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
Exclusion Criteria
Women who
are unable to communicate in Norwegian or
English, and women with a known allergy to
misoprostol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate <br>the effectiveness of vaginal misoprostol on <br>cervical priming measured as the largest size of <br>Hegar dilator (mm) inserted without resistance <br>prior to hysteroscopy in non-pregnant, <br>pre-menopausal and post-menopausal women. <br>Null-hypothesis: there is no clinically <br>significant difference in pre-operative baseline <br>cervical dilatation (<1mm), between women who <br>receive misoprostol and women who receive <br>placebo.;Secondary Objective: The number <br>of women who achieve satisfactory cervical <br>priming (cervical dilatation > = 5 mm). Number <br>of dilatations judged as easy or difficult. <br>Frequency of complications. Acceptability of <br>self-administration of vaginal capsules at <br>home.;Primary end point(s): Pre-operative <br>baseline cervical dilatation (mm) in the two <br>treatment groups.
- Secondary Outcome Measures
Name Time Method