Misoprostol before examination of the womb to facilitate this procedure.
- Conditions
- Reduction of pain during hysteroscopyTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2011-005160-23-NL
- Lead Sponsor
- VU medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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
Allergy for misoprostol
Previous cervical surgery or hysteroscopy
Active infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Reduction of pain;Secondary Objective: Reduction on operating time<br>Feasibility<br>Complications<br>Adverse events;Primary end point(s): Pain measured by continuous pain score meter;Timepoint(s) of evaluation of this end point: Peri-operative
- Secondary Outcome Measures
Name Time Method Secondary end point(s): VAS score (on a 0-10 scale)<br>AUC (area under the curve);Timepoint(s) of evaluation of this end point: Shortly pre-operative, peri-operative and directly post-operative