Misoprostol for cervical priming prior to hysteroscopy in postmenopausal and premenopausal nulliparous women; a multicentre randomised placebo controlled trial
Tasma, M L; Louwerse, M D; Hehenkamp, W J; Geomini, P M; Bongers, M Y; Veersema, S; van Kesteren, P J; Tromp, E; Huirne, J A; Graziosi, G C
(2018) BJOG - An International Journal of Obstetrics and Gynaecology, volume 125, issue 1, pp. 81 - 89
(Article)
Abstract
Objective: To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women. Design: Randomised multicentre double-blind placebo controlled trial. Setting: Two Dutch teaching hospitals and one Dutch university medical centre. Population: Postmenopausal and premenopausal nulliparous women undergoing office hysteroscopy. Methods: Patients
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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. Main outcome measures: 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]. Conclusion: Misoprostol prior to hysteroscopy reduces pain in premenopausal nulliparous women but not in postmenopausal women. It does cause side effects. Tweetable abstract: RCT: misoprostol versus placebo prior to hysteroscopy in 149 women significantly reduces some pain parameters.
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Keywords: Hysteroscopy, misoprostol, pain, continuous pain score meter, CPSM, Humans, Middle Aged, Hysteroscopy/methods, Operative Time, Oxytocics/administration & dosage, Postmenopause, Preoperative Care/methods, Adult, Female, Parity, Cervix Uteri/drug effects, Double-Blind Method, Drug Administration Schedule, Premenopause, Pain, Postoperative/prevention & control, Treatment Outcome, Misoprostol/administration & dosage, Ambulatory Surgical Procedures, Gastrointestinal Diseases/chemically induced, Pain Measurement, Obstetrics and Gynaecology, Journal Article, Randomized Controlled Trial, Multicenter Study, Comparative Study
ISSN: 1470-0328
Publisher: Wiley-Blackwell
Note: Funding Information: St Antonius Hospital Investigational Funds. Amount: ?9000. All analyses were performed independently from the funding source. We thank all the patients who willingly consented to the study. We would like to express our special gratitude to our co-workers at the clinical pharmacy in the St Antonius Hospital and at all three research departments: Rifka Peeters, Sandra Otten, Kathy Swart, Coby van Dam, Anja van Ommering and Ted Korsen. Without them it would have been impossible to carry out this study. Also we would like to thank the nurses and assistants present at the actual hysteroscopies; their enthusiasm and support with the CPSM were indispensable. Finally, special thanks to our interns, Timo Broeder and Suzanne Dedden, for their contribution to the study protocol and data management. Publisher Copyright: © 2017 Royal College of Obstetricians and Gynaecologists
(Peer reviewed)