Reduction of pain during hysteroscopy
Conditions
Interventions
Trade Name: Cytotec
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
VU medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Indication for diagnostic or therapeutic hysteroscopy Nulliparity if premenopausal Postmenopausal state (>1 year after last menstruation) Adequate command of the dutch language Informed consent Are the trial subjects under 18? no 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 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: Allergy for misoprostol Previous cervical surgery or hysteroscopy Active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of pain;Secondary Objective: Reduction on operating time Feasibility Complications Adverse events;Primary end point(s): Pain measured by continuous pain score meter;Timepoint(s) of evaluation of this end point: Peri-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): VAS score (on a 0-10 scale) AUC (area under the curve);Timepoint(s) of evaluation of this end point: Shortly pre-operative, peri-operative and directly post-operative | — |
Countries
Netherlands
Contacts
Public ContactW. Hehenkamp
VU medical center
Outcome results
None listed