Intrauterine pathology
Conditions
Interventions
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
Sponsors
Department of
Gynaecology, Helse Finnmark, Klinikk
Hammerfest
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Women who are unable to communicate in Norwegian or English, and women with a known allergy to misoprostol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ( = 5 mm). Number of dilatations judged as "easy" or "difficult". Frequency of complications. Acceptability of self-administration of vaginal capsules at home.;Primary end point(s): Pre-operative baseline cervical dilatation (mm) in the two treatment groups. | — |
Countries
Norway
Outcome results
None listed