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IRCT20140224016705N13 IRCT 2022-11-05 Shahid Beheshti University of Medical Sciences Hyoscine before hysteroscopy Comparing injectable Hyoscine and vaginal misoprostol in cervical ripening before hysteroscopy 2022-05-22 anticipated 120 Complete https://irct.ir/trial/63094 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Individual simple randomization using rand function of Excel software Every patient who is admitted to the hospital and placed in the hysteroscopy operation list is randomly assigned to one of the two groups of hyoscine or misoprostol using Excel software. Every day two to three people visit the hospital and they are allocated to the hyoscine or misoprostol category using randomization software, Blinding description: double blind study the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention. A placebo intramuscular ampoule is also prescribed for the patients, and in the misoprostol group, a vaginal pill is inserted during the examination. 2 Condition 1: cervical stenosis,. Condition 2: Endometrial polyp. Intervention 1: Intervention group: Misoprostol.The people of this group are prescribed 200microgram of misoprostol single dose in the form of vaginal tablets on the morning of the surgery during the examination. cytotec misoprostol is prescribed in Mahdieh hospital. Intervention 2: Intervention group: Hyoscine. These people are given a 20 mg ampoule of hyoscine purchased from Alborz daru company in the morning which is administered intramuscularly. Yes - There is a plan to make this available What will be shared: Information about patient data that is included in the analysis and data about the main outcome can be shared. When: 6 months after publication To whom: All academic and industrial researchers can access data. Conditions: metanalysis could be done on our data. Where to obtain: Applicants must send an e-mail in English stating the reason for using the data and the type of analysis. The email will be answered within 10 working days and the information file will be made available to them. How to obtain: An email will be sent in English stating the reason for using the data and the type of analysis and will be answered within 10 working days. Comments:
public Dr. Zahra Heidar
Mahdieh Hospital
Tehran Iran (Islamic Republic of) 1985717443 +98 21 5506 6288 dr_zheidar@yahoo.com Shahid Beheshti University of Medical Sciences scientific Zahra Heidar
Shoush square, Shishe gar khane street, Mahdie hospital
Tehran Iran (Islamic Republic of) 1185817311 +98 21 4461 2416 dr_zheidar@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All people who underwent hysteroscopy in Mahdieh Hospital no limit no limit Female People who are allergic to prostaglandins or hyoscine. People with a history of cervical injury or surgery. People with active cervical infection. Glaucoma History of cardiovascular disease and tachycardia People have recently been treated with estrogen. pregnancy N88.2 N84.0 Stricture and stenosis of cervix uteri Polyp of corpus uteri Prevention Prevention Intervention group: Misoprostol.The people of this group are prescribed 200microgram of misoprostol single dose in the form of vaginal tablets on the morning of the surgery during the examination. cytotec misoprostol is prescribed in Mahdieh hospital. Intervention group: Hyoscine. These people are given a 20 mg ampoule of hyoscine purchased from Alborz daru company in the morning which is administered intramuscularly. Cervical lacerations rate. Timepoint: during hysteroscopy. Method of measurement: presence of lacerations or canals. Entrance of hysteroscope into cervix. Timepoint: Start of hysteroscopy. Method of measurement: Likert scale. Uterine perforations. Timepoint: During surgery. Method of measurement: Based on serum deficit or surgeon experience. Post-op pain/ use of analgesics. Timepoint: for 24 hours after procedure. Method of measurement: Visual Analogue Scale. Drug side effects. Timepoint: 12 hours after drug administration. Method of measurement: based on patient vital signs and general conditions. Shahid Beheshti University of Medical Sciences Approved 2019-08-27 Ethics committee of Shahid Beheshti University of Medical Sciences Koodakiar street, Shahid beheshti medical university Tehran Tehran Iran (Islamic Republic of)