Randomized Control Trial Comparing Patient Acceptability and Tolerance to Pain Using Oral Versus Vaginal Misoprostol for Cervical Priming Before Office Hysteroscopy.

Brief Summary

Detailed Description

Sample size calculation was done using the comparison of pain sensation represented through VAS between oral and vaginal misoprostol for cervical ripening before office hysteroscopy. As reported in previous publication (Sordia-Herna'ndez et al., 2011), the mean ±SD of VAS in oral misoprostol group was approximately 6.04 ± 1.5, while in vaginal misoprostol group was approximately 2.8 ± 1.2. Accordingly, we calculated that the minimum proper sample size was 23 women in each arm to be able to detect a real difference of 1 unit with 80% power at α = 0.05 level using Student's t test for independent samples. Sample size calculation was done using Stats Direct statistical software version 2.7.2 for MS Windows, StatsDirect Ltd., Cheshire, UK However, the study population consists of 100 patients in reproductive age that requires diagnostic hysteroscopy for investigation of infertility or AUB. The patients will be recruited from Office hysteroscopy clinic of the Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University from October 2017 to march 2018. The Patients will be allocated equally into 2 groups ( each group contain 50 patients) Groups will be as follows: 1. Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before the procedure. 2. Group B: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before the procedure moistened with saline solution will be inserted in posterior fornix of vagina.

Primary Outcomes

Secondary Outcomes

• Bleeding(during the procedure.)
• Ease of cervical entry by hysteroscopy(The VAS will be applied immediately after the procedure ended.)
• Procedure time(it will be reported immediately after the process ended)