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IRCT20201028049169N1 IRCT 2020-11-02 Tehran University of Medical Sciences Comparison of the effect of Evening primrose oil with vaginal misoprostol in softening of the cervix before myomectomy hysteroscopy in Yas Hospital Comparison of the effect of Evening primrose oil with vaginal misoprostol in softening of the cervix in patients candidate for myomectomy hysteroscopy in Yas Hospital 2020-2022: a Randomized Clinical Trial 2020-11-21 anticipated 118 Complete https://irct.ir/trial/51973 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule: First, 59 letters A and 59 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A or B are determined by a lot, Blinding description: This study is performed as double-blind, the surgeon (the person performing the hysteroscopy), and the analyzer do not know the type of treatment. The drug is used by the resident physician for the patient based on the patient group the night before the hysteroscopy. 3 Uterine Leiomyoma. Intervention 1: Intervention group: 6 hours before hysteroscopy for cervix ripening, 200 micrograms of vaginal misoprostol from Samisaz pharmaceutical company is placed in the posterior part of the vagina. Intervention 2: Control group: 6 hours before hysteroscopy for cervix ripening two 500 mg capsules of Evening primrose oil from Daana pharmaceutical company is placed in the posterior part of the vagina. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants When: After manuscript published To whom: No limitations Conditions: The data is only available to the project manager, Dr. Valdan, and any analysis must be done with her opinion. Where to obtain: Dr. Mehrnaz Valdan How to obtain: Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Valdan. Comments:
public Sahar Garfami
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8608 9089 sahar.garfami87@yahoo.com Tehran University of Medical Sciences scientific Mehrnaz Valadan
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8608 9089 mehrnaz_valadan@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) All non-menopausal nulliparous women or Gravid One women with a history of one cesarean section The age group of 25 to 75 years 25 years 75 years Female people with a history of schizophrenia or epilepsy taking phenothiazines, structural cervical abnormalities such as a history of cervical insufficiency, Müllerian anomaly, and history of conization The unwillingness of people to participate in the study Allergy to Evening primrose oil or misoprostol contraindications for Evening primrose oil or misoprostol using such as coagulation disorders or concomitant consumption of anticoagulants drug D25 Leiomyoma of uterus Treatment - Drugs Treatment - Drugs Intervention group: 6 hours before hysteroscopy for cervix ripening, 200 micrograms of vaginal misoprostol from Samisaz pharmaceutical company is placed in the posterior part of the vagina. Control group: 6 hours before hysteroscopy for cervix ripening two 500 mg capsules of Evening primrose oil from Daana pharmaceutical company is placed in the posterior part of the vagina. The cervix dilatation measurement. Timepoint: Once, Before hysteroscopy. Method of measurement: The Hegar dilator size using for hysteroscopy. Tehran University of Medical Sciences Approved 2020-10-12 Ethics committee of Tehran University of Medical Sciences ehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St Tehran Tehran Iran (Islamic Republic of)