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IRCT20230404057817N1 IRCT 2023-05-08 Qazvin University of Medical Sciences The effects of evening primrose oil in preparing the cervix before hysteroscopic surgeries Comparison of the effect of misoprostol and evening primrose oil on cervical dilatation before hysteroscopic surgery 2023-06-05 anticipated 120 Complete https://irct.ir/trial/69435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to ease of use and saving time, the participants were divided into two groups using random sequence generation software. In this way, information such as the sample size and the number of groups is given to the software (Random allocation software) and the software provides a table of random numbers in which the letters A and B are randomly assigned to each number. In this study, numbers with letter A are in the intervention and numbers with letter B are in the control group, Blinding description: The study is double blind. In each of the groups, the desired capsule is placed in the posterior fornix of the vagina by the resident 6 to 8 hours before hysteroscopy. The surgeon and the patients will not know the type of drug used, and before the surgeon enters, the removal of the probe and the drape will be done by another person, and if there is a vaginal pill, the pill will be removed so that the surgeon does not notice the presence of the vaginal pill and its type. 3 Hysteroscopy. Intervention 1: Intervention group: In patients of this group, 2 capsules of 500 mg evening primrose oil ( Abidi Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 to 8 hours before hysteroscopy. Intervention 2: Control group: In patients of this group, 2 capsules of 200 micrograms of misoprostol (Samisaz Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 to 8 hours before hysteroscopy. Yes - There is a plan to make this available What will be shared: The collected information which is in the form of a questionnaire can be shared. When: The start of the access period is one year after the results are published. To whom: For obstetricians and researchers working in academic institutions Conditions: Evaluate the path and process of study and analyze it Where to obtain: For information, refer to Dr. Farkhondeh Ghavampour. The communication channels are as follows: By sending an email to the address: mahdieghavampoor@yahoo.com or referring and contacting Kosar Hospital at the address: Qazvin, Taleghani St. Phone: 028-33236374 Postal address: 34156-13176 How to obtain: After sending the e-mail, the requested information will be reviewed by the facilitator and the person responsible for the scientific responsibility of the study. At your discretion, the requested information will be sent within 10 days of receiving the email Comments:
public Farkhondeh Ghavampour
Bahonar Blvd, Qazvin
Qazvin Iran (Islamic Republic of) 3413786313 +98 28 3333 6001 mahdieghavampoor@yahoo.com Qazvin University of Medical Sciences scientific Venus Chegini
Kosar Hospital, Taleghani St., Qazvin
Qazvin Iran (Islamic Republic of) 13176- 34156 +98 28 3323 6374 mahdieghavampoor@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Menopausal women or women of reproductive age with no history of normal vaginal delivery (NVD) Closure of the cervix no limit no limit Female Women with cervical structural abnormalities and a history of cervical insufficiency Women with Müller malformations Women with a history of conization Women with any contraindications to EPO or misoprostol (EPO or misoprostol contraindications such as seizures, asthma, high blood pressure, glaucoma, etc.) Women who have a history of failed hysteroscopy or D&C due to severe cervical stenosis. Treatment - Drugs Treatment - Drugs Intervention group: In patients of this group, 2 capsules of 500 mg evening primrose oil ( Abidi Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 to 8 hours before hysteroscopy. Control group: In patients of this group, 2 capsules of 200 micrograms of misoprostol (Samisaz Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 to 8 hours before hysteroscopy. The time to reach the required dilatation (3 to 7 mm). Timepoint: From the start of the operation until reaching the required expansion. Method of measurement: Clinical. Cervical rupture. Timepoint: Immediately after the patient regains consciousness. Method of measurement: Clinical observations. Perforation of the uterus. Timepoint: Immediately after the patient regains consciousness. Method of measurement: Clinical observations. Side effects. Timepoint: Immediately after the patient regains consciousness. Method of measurement: Clinical observations. Qazvin University of Medical Sciences Approved 2023-03-06 Ethics Committee of Qazvin University of Medical Sciences Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd Qazvin Qazvin Iran (Islamic Republic of)