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IRCT20230316057738N1 IRCT 2023-05-19 Kerman University of Medical Sciences Investigating the effect of tranexamic acid drug on bleeding and surgical outcomes of myoma removal through hysteroscope Tranexamic acid (TXA) - Normal salin (N.S) Investigating the effect of intrauterine tranexamic acid on bleeding and the outcome of it in hysteroscopic myomectomy 2023-05-22 anticipated 60 Complete https://irct.ir/trial/69579 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the Restricted randomization method of block block randomization 1:1, and the patients will be divided into two groups: placebo (30 people) or intervention (30 people) and the drug intervention group (tranexamic acid) 10 mg/kg) and placebo (normal saline) will be given to the other group. (Blocking is usually used in order to balance the number of samples allocated to each of the studied groups. This feature helps researchers to increase the number of samples in cases where intermediate analyzes are needed during the sampling process. allocated to each of the studied groups is the same) the size of all the blocks is equal and in this experiment we will have two groups of 6 blocks (including 3 participants in the intervention group and 3 participants in the control group) had The randomization tool is also used from software allocation random sequence generation software, which in addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method, Blinding description: An independent person (statistician) who is involved in the treatment or collection of data will be sealed with consecutive numbers. The principal investigator, the patients, and the surgeon performing the surgery will all be blinded to the trial. All participants will undergo a thorough clinical evaluation including: detailed history, general and pelvic examination, transvaginal ultrasound to determine the number, size and location of myomas. After preparing the history and clinical examinations, blood samples of the patients will be prepared and the necessary tests (CBC), PT, PTT and INR will be done for them before the surgery. Also, drug or placebo is prescribed using a specific coding system, and the surgical team and the patient themselves do not know the type of drug used. 3 Uterus myoma. Intervention 1: Intervention group: as soon as the hysteroscope enters the uterus, an ampoule of tranexamic acid from Iran Daru 10 mg/kg will be injected into the uterus.p:. Intervention 2: Control group: As soon as the hysteroscope enters the uterus, 5 cc of normal saline will be injected into the uterus. Yes - There is a plan to make this available What will be shared: All of datas When: Starting from six months after the publication of the article To whom: Researchers, students and doctors Conditions: To conduct a clinical trial Where to obtain: Public or scientific responsible person How to obtain: Send the proposal to the responsible person's email Comments:
public Nadia Arabpour amroudi
Vasal Alley 1 , Vasal St.
Kerman Iran (Islamic Republic of) 7617945661 +98 34 3216 8180 arabpour.nadia@gmail.com Kerman University of Medical Sciences scientific Nadia Arabpour Amroudi
Vasal Alley 1, Vasal St.,
Kerman Iran (Islamic Republic of) 7617945661 +98 34 3216 8180 arabpour.nadia@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Have a single myoma Grade 0, 1, and 2 myomas Myomas smaller than 4 cm 18 years 60 years Female Have intracranial bleeding Have any sensitivity to the drug tranexamic acid Have thromboembolic and ischemic heart diseases There are uterine abnormalities Have an active pelvic infection Have a history of hemorrhagic disease Pregnancy Previous hystreroscopy surgery D25.9 Leiomyoma of uterus, unspecified Treatment - Drugs Treatment - Drugs Intervention group: as soon as the hysteroscope enters the uterus, an ampoule of tranexamic acid from Iran Daru 10 mg/kg will be injected into the uterus.p: Control group: As soon as the hysteroscope enters the uterus, 5 cc of normal saline will be injected into the uterus Better vision during surgery. Timepoint: During surgery. Method of measurement: Surgeon rating. Bleeding during surgery. Timepoint: During surgery. Method of measurement: Surgeon rating. Duration of operation. Timepoint: From the beginning of surgery to the end of surgery. Method of measurement: Minutes. Hemoglobin reduction rate. Timepoint: Before the operation and 24 hours after the operation. Method of measurement: Milligram on deciliter. Complications of the operation. Timepoint: During or after surgery. Method of measurement: Patient symptoms. The completeness of the operation in one step. Timepoint: One month after surgery. Method of measurement: Sonography. Kerman University of Medical Sciences Approved 2023-05-01 Ethics Committee of Kerman University of Medical Sciences University of Medical Sciences Campus,The beginning of Haft Bagh Alavi Boulevard, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)