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IRCT20191123045476N4 IRCT 2023-09-01 Iran University of Medical Sciences Investigating nitroglycerin and misoprostol on cervical ripening Comparative effect of sublingual Nitroglycerin and sublingual Misoprostol on Cervical ripening before Hysteroscopy 2023-06-20 anticipated 84 Complete https://irct.ir/trial/70601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: In this study, the main researcher and the data analyst will be blinded to the assignment of the study groups; The patients are given a special code and the analyst does not know which group A and B are, and the main researcher is not involved in the selection of patients and does not know which group the patient who is undergoing surgery belongs to. 3 Hysteroscopy candidate patients. Intervention 1: Intervention group 1: 42 patients under general anesthesia receive sublingual nitroglycerin (Zahrawi Company, Iran) at a dosage of 0.4 mg 30 minutes before the operation. Intervention 2: Intervention group 2: 42 patients receive misoprostol tablets (manufactured by Zahrawi Pharmaceutical Company) at a dosage of 200 micrograms sublingually 6 hours before surgery. Yes - There is a plan to make this available What will be shared: After the article is published, confidential information such as patient and hospital details will be removed and other information will be provided to the researchers. When: After publishing the article To whom: Medical specialists Conditions: Medical professionals can access the data for research purposes. Where to obtain: Refer to the email of the responsible author. How to obtain: Official and academic email to the responsible author Comments:
public Samaneh Rokhgireh
Rasoul Akram Hospital, Mansouri Street, Starkhan, Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6650 9283 Rokhgireh.s@iums.ac.ir Iran University of Medical Sciences scientific Samaneh Rokhgireh
Rasoul Akram Hospital, Mansouri Street, Starkhan, Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6650 9283 Rokhgireh.s@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) age between 18-50 years (reproductive age) history of at least one Normal Vaginal Delivery being a candidate for hysteroscopy 18 years 50 years Female history of drug allergy cardiovascular diseases Treatment - Drugs Treatment - Drugs Intervention group 1: 42 patients under general anesthesia receive sublingual nitroglycerin (Zahrawi Company, Iran) at a dosage of 0.4 mg 30 minutes before the operation. Intervention group 2: 42 patients receive misoprostol tablets (manufactured by Zahrawi Pharmaceutical Company) at a dosage of 200 micrograms sublingually 6 hours before surgery. Cervical dilatation. Timepoint: Immediately after taking the drug during surgery. Method of measurement: In the operating room, the opening of the cervix is measured in millimeters using sized dilators. Iran University of Medical Sciences Approved 2023-05-28 Ethics committee of Iran University of Medical Sciences Iran University of medical sciences, Hammat highway, Tehran Tehran Tehran Iran (Islamic Republic of)