Hysmis study.Misoprostol for cervical priming prior to hysteroscopy in postmenopausal or nulliparous women; a multi-centre randomised placebo controlled trial.
- Conditions
- Hysteroscopy/hysteroscopiePain/pijnMisoprostol
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 136
Inclusion Criteria
Indication for diagnostic or therapeutic hysteroscopy
Nulliparity if premenopausal
Exclusion Criteria
Allergy for Misoprostol
Previous cervical surgery or hysteroscopy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain measured by a continuous pain score meter
- Secondary Outcome Measures
Name Time Method the postoperative pain measured directly after the procedure measured as VAS-score by questionnaire (questionnaire nr 3)<br>the pain during passage of the cervix measured as the Peak Pain Score (PPS) and the Average Pain per Second (APS)<br>the total experienced pain during the procedure measured as AUC and PPS<br>the level of difficulty of the hysteroscopy experienced by the surgeon, measured by a Likert 5-point Scale<br>the total operating time <br>the duration of cervical passage<br>the intra-operator differences<br>the differences in pain score between vaginal nullipara and multipara<br>the acceptability of the procedure again<br>the preference to undergo the procedure under general anesthesia<br>adverse events including nausea, vomiting, diarrhoea, fever, abdominal pain and vaginal bleeding<br>complications such as perforation, bleeding, nausea, vomiting, syncope and heavy pain