title: Misoprostol for cervical priming prior to hysteroscopy in postmenopausal and premenopausal nulliparous women; a multicentre randomised placebo controlled trial.
abstract: OBJECTIVE
  To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women.
  
  
  METHODS
  Randomised multicentre double-blind placebo controlled trial.
  
  
  METHODS
  Two Dutch teaching hospitals and one Dutch university medical centre.
  
  
  METHODS
  Postmenopausal and premenopausal nulliparous women undergoing office hysteroscopy.
  
  
  METHODS
  Patients were randomised to receive either 400 microgram misoprostol or placebo 12 and 24 hours before hysteroscopy. Pain was quantified by the use of real time pain measurement using the continuous pain score meter (CPSM) and VAS scores.
  
  
  METHODS
  Primary outcome was pain measured by the CPSM during passage of the hysteroscope through the cervical canal, quantified by the area under the curve (AUC). Secondary outcomes included VAS scores, other CPSM parameters, failures and side effects.
  
  
  RESULTS
  In all, 149 patients were randomly assigned to either misoprostol (n = 74) or placebo (n = 75). The AUC during introduction did not significantly differ between the intervention and the placebo group. The VAS score during introduction, however, demonstrated a significant difference in premenopausal nulliparous women favouring misoprostol: 2.9 (95% CI 1.3-4.4) versus placebo 5.5 (95% CI 3.9-7.1), P = 0.02, as well as the AUC during the entire procedure: 618 (95% CI 410-827) versus 1126 (95% CI 671-1580), P = 0.04. Failures were equally distributed between the misoprostol (16%) and placebo group (13%). Intestinal side effects occurred significantly more frequently in the misoprostol group (67%) than in the placebo group (32%) [OR 4.2 (95% CI 2.1-8.3), P < 0.01].
  
  
  CONCLUSIONS
  Misoprostol prior to hysteroscopy reduces pain in premenopausal nulliparous women but not in postmenopausal women. It does cause side effects.
  
  
  CONCLUSIONS
  RCT: misoprostol versus placebo prior to hysteroscopy in 149 women significantly reduces some pain parameters.
authors.affiliation: Amphia Hospital, Breda, the Netherlands.
authors.forename: M L
authors.initials: ML
authors.lastname: Tasma
authors.affiliation: VU University Medical Centre, Amsterdam, the Netherlands.
authors.forename: M D
authors.initials: MD
authors.lastname: Louwerse
authors.affiliation: VU University Medical Centre, Amsterdam, the Netherlands.
authors.forename: W J
authors.initials: WJ
authors.lastname: Hehenkamp
authors.affiliation: Maxima Medical Centre, Veldhoven, the Netherlands.
authors.forename: P M
authors.initials: PM
authors.lastname: Geomini
authors.affiliation: Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: M Y
authors.initials: MY
authors.lastname: Bongers
authors.affiliation: St. Antonius Hospital, Nieuwegein, Utrecht, the Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: Veersema
authors.affiliation: OLVG Oost Hospital, Amsterdam, the Netherlands.
authors.forename: P J
authors.initials: PJ
authors.lastname: van Kesteren
authors.affiliation: St. Antonius Hospital, Nieuwegein, Utrecht, the Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Tromp
authors.affiliation: VU University Medical Centre, Amsterdam, the Netherlands.
authors.forename: J A
authors.initials: JA
authors.lastname: Huirne
authors.affiliation: St. Antonius Hospital, Nieuwegein, Utrecht, the Netherlands.
authors.forename: G C
authors.initials: GC
authors.lastname: Graziosi
mesh_terms: D000328:Adult; D000556:Ambulatory Surgical Procedures; D002584:Cervix Uteri / Q000187:drug effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D015907:Hysteroscopy / Q000379:methods*; D008875:Middle Aged; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D061646:Operative Time; D010120:Oxytocics / Q000008:administration & dosage* / Q000009:adverse effects; D010147:Pain Measurement; D010149:Postoperative Pain / Q000517:prevention & control; D010298:Parity; D017698:Postmenopause; D017697:Premenopause; D011300:Preoperative Care / Q000379:methods; D016896:Treatment Outcome
chemical_list: D010120:Oxytocics; D016595:Misoprostol
keywords: CPSM; Hysteroscopy; continuous pain score meter; misoprostol; pain