se of misoprostol before hyteroscopy exam to evaluate intrauterine in postmenopausal women.
Phase 4
- Conditions
- Endometrial polyps. Postmenopausal bleeding.N95.0
- Registration Number
- RBR-9py4kd
- Lead Sponsor
- niversidade Estadual de Campinas - UNICAMP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
182 Menopausal women with minimum age of 50 and maximum of 80 referred for endometrial assessment by hysteroscopy.
Exclusion Criteria
Women with lower genital tract infection.
Women who have had intrauterine diseases that were previously treated by endoscopy.
Women who have never had sexual relations; with uterine malformation; with mental disabilities or undergoing pelvic radiotherapy.Women who refused to participate in the study.Women who had metrorrhagia during the exam.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EXPECTED OUTCOME: Lower pain during the procedure, the clamping of the cervix and at the time of biopsy will evaluete by visual pain score that will show lower values in the misoprostol group.
- Secondary Outcome Measures
Name Time Method EXPECTED OUTCOME: Equal need for cervical dilatation between groups ( misoprostol or placebo) that will be evaluated by the passage of a hysteroscope through the cervix and / or dilation of the external orifice using Hegar number 1 to 4.;EXPECTED OUTCOME: Similar procedure time between groups (misoprostol or placebo)that will be evaluated by timer starting in the passage of the hysteroscope through the cervix and ending the withdrawal the instrument, measured in minutes.;EXPECTED OUTCOME: The frequency of side effects will be 5% and will be evaluated by the account of the women that will show little effects by drugs.;EXPECTED OUTCOME: Less cost-effective with the use of misoprostol in hysteroscopy that will be evaluated by pharmacoeconomic study to assess how misoprostol reduce the number of hysteroscopy under anesthesia.