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

INTERVENTION: Trade Name: Cytotec Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Reduction of pain during hysteroscopy Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: Reduction of pain Primary end point(s): Pain measured by continuous pain score meter Secondary Objective: Reduction on operating time; Feasibility; Complications; Adverse events Timepoint(s) of evaluation of this end point: Peri‐operative SECONDARY OUTCOME: 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 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