Hysmis study.
Misoprostol for cervical priming prior to hysteroscopy in postmenopausal or nulliparous women; a multi-centre randomised placebo controlled trial.

When a woman is experiencing abnormal uterine bleeding and/or is suspected of an uterine cavity abnormality the common procedure is a diagnostic or therapeutic hysteroscopy. Other reasons for hysteroscopy comprehend sub fertility, recurrent pregnancy loss and sterilization.
Most often hysteroscopy requires extended dilatation of the cervix. There are different procedures to perform a hysteroscopy. In our hospital we perform the vaginoscopic also known as the Bettocchi procedure. Especially in postmenopausal women difficulties can be encountered, since cervical changes decrease elasticity and increase the level of obliteration. Dilating the cervix can be a painful event and tends to be more painful in nulliparous women and in postmenopausal stage. Pain is the reason for failure of hysteroscopy in up to 75% of all cases failed.
Local or general anaesthesia is a time-consuming and not a risk less event which is only to be used when absolutely necessary. Therefore another way of reducing pain is preferred. According to literature cervical ripening and/or dilatation could be facilitated by Misoprostol thus reducing pain.
The few studies performed in postmenopausal patients are conflicting regarding improvement in cervical dilatation and ease of the procedure with previous use of Misoprostol. More research is needed.

Objective: To evaluate the benefit of Misoprostol prior to hysteroscopy in nulliparous and postmenopausal women regarding the reduction of pain.

Misoprostol prior to hysteroscopy in nulliparous and postmenopausal women will reduce pain during the procedure.

4 moments for measurement: 1. questionnaire before intake of study medication, 2. questionnaire right before the hysteroscopy, 3. use of the continuous pain score meter during the hysteroscopy, 4. questionaire after the hysteroscopy.

Treatment exists of Misoprostol (a prostaglandine E1-analogue) compared to placebo. Misoprostol ripens the cervix. Therefore the hypothesis is that Misoprostol decreases the pain experienced during hysteroscopy. This is our primary outcome: pain, measured by a continuous pain score meter and a VAS-score.Intervention- and control-groups are similar, randomisation is double blinded. Patients are either postmenopauzal or premenopauzal nullipara. The duration of the intervention is 24 and 12 hours before the hysteroscopie. The patient takes either Misoprostol or placebo, double blinded.