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IRCT20150909023949N9 IRCT 2018-11-24 Iran University of Medical Sciences Comparing crocin and misoprostol effects on cervical ripening Comparing effects of crocin and misoprostrol consumption on cervical ripening in women undergoing operative hysteroscopy: a randomised clinical trial 2019-01-05 anticipated 50 Complete https://irct.ir/trial/33889 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Iran is considered one of the main countries which export saffron, therefore, any study highlighting the value of this herb in medicine could be of significant importance in improving the economic conditions of the society. This would be the first study which assess the effects of one of the main constituents of saffron on cervical softening which could have desirable outcomes in the minimally invasive surgical procedures used in the gynecology field, Randomization description: In this study, 50 women who are candidates for hysteroscopy will be divided into two groups of control and case (25 each).Using a table of random numbers, a number from 1 to 50 is attributed to each patient. Crocin tablets will be given to odd numbers as the case group and misoprostol tablets will be given to even numbers as the control group, Blinding description: The patients receiving the tablets and the surgeon performing the hysteroscopy are blind to the study. Tablets put in enclosed opaque envelopes will be numbered َA or B and will be given to patients by a third person unaware of the study. 3 Condition 1: Uterine polyp. Condition 2: endometrial hyperplasia. Condition 3: submucosal fibroid. Condition 4: Abnormal uterine bleeding. Condition 5: excessive bleeding in the premenopausal period. Intervention 1: Intervention group: Two crocin 15 mg tablets (Sami Saz Co. mashhad) are given to patients at 6 pm and 12 midnight before surgery. Intervention 2: Control group: Two misoprostol 100 microgram (CYTOTEC ,Pfizer Co.) tablets are given at 6 pm and 12 midnight before surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information available.
public Mansoureh Vahdat
Rasoul-e-Akram Hospital, Niayesh St., Sattarkhan Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2562 vahdat.m@iums.ac.ir Iran University of Medical Sciences scientific Mansoureh Vahdat
Rasoul-e-Akram Hospital, Niayesh St., Sattarkhan Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2562 vahdat.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) All women who are scheduled for operative hysteroscopy No history of allergy to saffron or prostaglandins Having written informed consent 18 years no limit Female Suffering from active hepatic, renal, hematologic or cardiologic disorder Approved known malignancy of genital tract Approved cervical insufficiency N84.0 N85.0 D25.0 Polyp of corpus uteri Endometrial glandular hyperplasia Submucous leiomyoma of uterus Treatment - Drugs Treatment - Drugs Intervention group: Two crocin 15 mg tablets (Sami Saz Co. mashhad) are given to patients at 6 pm and 12 midnight before surgery. Control group: Two misoprostol 100 microgram (CYTOTEC ,Pfizer Co.) tablets are given at 6 pm and 12 midnight before surgery. Size of the largest dilator passed from cervical canal without resistance. Timepoint: After the induction of the anesthesia and before entering the hysteroscope in the operating room. Method of measurement: examination performed by the surgeon- Using standard dilators in the operating room. The extent of cervical tissue softening. Timepoint: After induction of anesthesia and before entering the hysteroscope in the operating room. Method of measurement: examination by the surgeon in the operating room. The length of time of the procedure till entering the uterine cavity. Timepoint: After induction of anesthesia in the operating room. Method of measurement: Using chronometer by the surgeon's assistant. Iran University of Medical Sciences Approved 2018-08-26 Ethics committee of Iran University of Medical Sciences Rasoul-e-Akram Hospital, Maziar Mansouri Street, Sattarkhan Street Tehran Tehran Iran (Islamic Republic of)