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IRCT20140525017827N12 IRCT 2021-08-23 Shiraz University of Medical Sciences Effect of eveing primrose oil in ripening of cervix before of gynecologic surgeries Primrose oil gel capsule on the Ease of Cervical Ripening Before Operative Hysteroscopy 2021-08-23 anticipated 100 Complete https://irct.ir/trial/55041 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Misoprostol and primrose oil gel capsules are the same appearance and characteristics and will be given to our colleague drug distributor in the form of A or B. The treatment allocation list is already designed on Block Balanced Randomization Method by the computer software. 1 (A), 2 (B), 3 (B), 4 (B), 5 (A),……. Any eligible patient will be given a 1 to 100 code after obtaining informed consent in order to visit the clinic and based on the above block, they receive A or B drug. The drug distributor doesn’t have a role in the treatment plan and data analysis. The patients, researcher, and data analyzer are not aware of the type of treatment for each patient. Finally, the patients will be followed by their own codes, Blinding description: 100 patients with incomplete abortion will be studied in two groups of 50. Patients will receive A or B medication based on randomized block in double blind method and a code will be allocated to each patient (1 to 100) that will be encoded at the end of the study. The patients and the designer and drug distributer are not aware of the drug pack. This study is the second phase of trial. 3 Cervical preparation before hysteroscopic surgery. Intervention 1: Intervention group: 2 capsules of evening primrose 1000 mg (made by webber naturals Canada with confirmation code 1505809997164877771629, UID: 15210012004109455083 and GTN: 062600847248841 Food: LOT: 1 The vagina is placed behind the fornix 4-6 hours before surgery. Intervention 2: Intervention group: 400 micrograms of misoprostol ( Pfizer company) 4-6 hours before surgery. Yes - There is a plan to make this available What will be shared: IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient When: IPD: 2021Ethic form: 2021 To whom: IPD: Researcher & Patient Ethic form: Patient Conditions: IPD: Ethic form: Awareness of test results Where to obtain: IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences How to obtain: IPD: Vice chancellery Ethic form: Vice chancellery Comments:
public Omolbanin Hasani
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3648 9830 banin.hassani5349@gmail.com Shiraz University of Medical Sciences scientific Nasrin Asadi
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 nasadi2012@yahoo.ca Shiraz University of Medical Sciences Iran (Islamic Republic of) Candidate for hysteroscopy Aged 18-50 years No pregnancy Consent to participate in the study Women who do not have a history of normal delivery or cervical manipulation Spinal anesthesia nulliparity 18 years 50 years Female Those who had a contraindication to PGs (history of severe asthma, glaucoma, preexisting cardiac disease, hypertension, or renal failure, bleeding disorders or consuming medications that inhibit blood clotting, Patients with a history of schizophrenia who take phenothiazines patients with epilepsy and seizure Significant uterovaginal prolapse precluding the administration of vaginal tablets. History of cervical incompetence Mullerian anomaly or a history of a cervical cone biopsy, General anesthesia BMI>35 N84.0 Polyp of corpus uteri Treatment - Drugs Treatment - Drugs Intervention group: 2 capsules of evening primrose 1000 mg (made by webber naturals Canada with confirmation code 1505809997164877771629, UID: 15210012004109455083 and GTN: 062600847248841 Food: LOT: 1 The vagina is placed behind the fornix 4-6 hours before surgery. Intervention group: 400 micrograms of misoprostol ( Pfizer company) 4-6 hours before surgery Size of first input hegar dilator. Timepoint: At the beginning of the study and immediately after the hysteroscopy (4-6 hours after taking the drug). Method of measurement: Measurement of cervical dilatation: Hegar dilator. Complications of the drug before, during and after hysteroscopy. Timepoint: After prescribing the drug (4-6 hours later) and immediately before the hysteroscopic surgery and during the operation. Method of measurement: Clinical observation. Cervical consistency after drug administration. Timepoint: After prescribing the drug (4-6 hours later) and immediately before the hysteroscopic surgery and during the operation. Method of measurement: Check the consistency of the cervix with a finger examination, Hegar Dilator. Duration of cervical dilatation. Timepoint: After prescribing the drug (4-6 hours later) and immediately before the hysteroscopic surgery and during the operation. Method of measurement: Timing. The total duration of surgery. Timepoint: During the operation. Method of measurement: Timing. Shiraz University of Medical Sciences Approved 2020-07-14 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz Shiraz Fars Iran (Islamic Republic of)