Randomized clinical trial, controlled, placebo use of misoprostol for postmenopausal women in the hysteroscopy

• Grant number: 13/13934-1
• Support type: Regular Research Grants
• Duration: June 01, 2014 - May 31, 2016
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal researcher: Daniela Angerame Yela Gomes
• Grantee: Daniela Angerame Yela Gomes
• Home Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil

Abstract

Hysteroscopy is considered by many authors as a gold standard test to assess when we exclude endometrial biopsy. However, this procedure may present some difficulties, especially in the passage of the device through the internal cervical. This difficulty is exacerbated when the procedure is performed on patients in post-menopausal women. Misoprostol has proved important, especially in regard to hysteroscopy in postmenopausal women. Many controlled trials suggest benefits in prior use of misoprostol to decrease the resistance of the uterine cervix, however this type of study is still scarce when comparing misoprostol prior to hysteroscopy in postmenopausal women. Objectives: To evaluate the effects of intra and post procedure in postmenopausal women, undergoing diagnostic hysteroscopy without anesthesia, with previous use of misoprostol for cervical ripening and cost-effectiveness of misoprostol in hysteroscopy. Subjects and methods: a detailed study clinical trial, double-masked, randomized, post-menopausal women who will undergo diagnostic hysteroscopy without anesthesia at the Center for Comprehensive Care of Women (CAISM) State University of Campinas (UNICAMP). Included, 158 patients will be randomly allocated into two groups, 79 with use of 200¼g of misoprostol vaginally and 79 with placebo. Will study the following variables: time of the procedure, frequency and intensity of pain during the procedure, need for cervical dilation additional side effects (genital bleeding, nausea, vomiting, diarrhea, hyperthermia) and complications (uterine perforation, false fistula, cervical laceration, infections, pain in the immediate post-procedure). Data analysis: For statistical analysis, we used the chi-square test of association, Fisher's exact test and Mann-Whitney test to compare the groups, and Student's t test orKruskal Wallu to evaluate the cost-effectiveness considering an alpha error of less than 5%. To perform these procedures will be used, SAS version 9.02. (AU)