To evaluate pain and determine the efficacy of misoprostol, compared with placebo, for postmenopausal women before diagnostic hysteroscopy.
This randomized, double-blind, placebo-controlled clinical trial included 158 postmenopausal women who received either 200 μg of misoprostol or placebo through the vaginal route before diagnostic hysteroscopy (79 women/group). The primary outcome was pain assessment (presence and intensity) during the four steps of hysteroscopy: cervical grasping with a Pozzi tenaculum forceps immediately before hysteroscopy, during hysteroscopy, during performance of the endometrial biopsy, and postprocedure. The secondary outcomes were duration of the procedure, need for additional cervical dilatation, complications, and adverse effects.
Mean ages of the women were 62 ± 8.2 years and 60 ± 7.3 years in the misoprostol and placebo groups, respectively. Abnormal bleeding (misoprostol group, 45.6%; placebo, 43%) and endometrial thickening (54.4% in the misoprostol group and 57% in the placebo group) were the most common indications for the examination in both groups (P = 0.49). There was no significant difference between groups in the pain intensity of the four steps of the procedure. The duration of hysteroscopy was similar in both groups (misoprostol group, 2.5 ± 2.7 minutes; placebo, 2.1 ± 1.6 minutes; P = 0.43). Additional cervical dilatation was needed in 11 women in the misoprostol group versus 9 in the placebo group (P = 0.63). In both groups, there was no significant difference in terms of complications. Adverse effects were reported by 25.3% of women using misoprostol (vaginal bleeding, 11.3%; cramping, 12.6%; diarrhea, 2.5%; 1 woman reported both vaginal bleeding and cramping). In the placebo group, only 2.5% of women developed adverse effects (P < 0.0001).
Misoprostol does not reduce pain intensity, the duration of the procedure, or need for additional cervical dilatation, and causes more adverse effects when used in postmenopausal women before diagnostic hysteroscopy.
Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, São Paulo, Brazil.
Address correspondence to: Daniela A. Yela, MD, PhD, Department of Obstetrics and Gynecology, University of Campinas (UNICAMP), 101 Alexander Fleming Street, Cidade Universitária, 13083-881 Campinas, SP, Brazil. E-mail: email@example.com
Received 8 November, 2017
Revised 5 January, 2018
Accepted 5 January, 2018
This study was presented at The North American Menopause Society 2017 Annual Meeting and was awarded the second place among all studies presented. It was also awarded one of the best works at the Brazilian Congress of Gynecology and Obstetrics in 2017.
Funding/support: This study was supported by Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP), Brazil.
Financial disclosure/conflicts of interest: None reported.
Clinical trial registration: ReBEC (Registration of Brazilian Clinical Trials), RBR-9py4kd.