]>
IRCT20220101053581N1 IRCT 2022-05-21 Gorgan University of Medical Sciences Survey of the effect of vaginal misoprostol on post myomectomy bleeding Determination of the effect of vaginal misoprostol on post myomectomy bleeding: A double-blind randomized clinical trial 2022-04-09 anticipated 68 Complete https://irct.ir/trial/61240 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were divided into control and intervention groups based on random allocation of quadruple blockade. For this purpose, the four blocks were selected so that the intervention group had the letter A and the control group the letter B. 6 possible modes were written on separate cards and each card was assigned a number from one to six. The numbers were then written on paper and removed randomly. Until the expected number of samples was completed. In this study, the online randomization service (http // www.sealedenvelope.com / simple-randomiser / v1 / lists) was used to block block randomization, Blinding description: Sequence concealment was performed using packets in packages. In this way, one of the letters was placed inside each envelope in the specified order and then the lid of the envelope was closed and given to the researcher. The use of random allocation largely controlled the confounding variables, but the research team also included potential confounding variables in the designed questionnaire and analyzed their effect. The researcher will also be unaware of the assignment of individuals in groups due to hiding the sequence of individuals in groups. 3 Uterine myoma. Intervention 1: After obtaining permission from the authorities and explanations about the method of intervention to patients and completing the form of demographic questionnaire, patients will be randomly divided into two groups of control and intervention. On the day of surgery before the start of the patient's surgery (in the patient preparation phase), patients with the intervention group will be administered 200 micrograms of misoprostol vaginally. Bleeding during the operation will then be estimated by the amount of gas and blood clot and suction. Intervention 2: patients in the control group, placebo (tablet B6) will be used vaginally before surgery and the amount of bleeding during the operation will be measured by measuring gas and blood clots and suction. Yes - There is a plan to make this available What will be shared: Part of the main outcome data includes personal information and the main outcome results When: Access period starts 6 months after the results are published To whom: researchers Conditions: Only researchers to conduct similar studies Where to obtain: Dr. Maryam Mazji Email: m_mazji@yahoo.com How to obtain: Correspond with the researcher via email Comments:
public Maryam Mazji
Sayad Shirazi Hospital, Gorgan
Gorgan Iran (Islamic Republic of) ۷۴۳۹-۴۹۱۷۸۶۷ +98 17 3220 2173 m_mazji@yahoo.com Gorgan University of Medical Sciences scientific Marzieh Zanganeh
Sayad Shirazi Hospital, Gorgan
Gorgan Iran (Islamic Republic of) ۷۴۳۹-۴۹۱۷۸۶۷ +98 17 3220 2173 marzieh.zanganeh90@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Myoma less than 8 cm in size on ultrasound married 18 years no limit Female Contraindications to misoprostol Hemorrhagic disease Active asthma High diastolic blood pressure Recent use of nonsteroidal anti-inflammatory drugs History of severe anemia; Allergies and recent blood transfusions D25.9 Leiomyoma of uterus, unspecified Treatment - Surgery Treatment - Surgery After obtaining permission from the authorities and explanations about the method of intervention to patients and completing the form of demographic questionnaire, patients will be randomly divided into two groups of control and intervention. On the day of surgery before the start of the patient's surgery (in the patient preparation phase), patients with the intervention group will be administered 200 micrograms of misoprostol vaginally. Bleeding during the operation will then be estimated by the amount of gas and blood clot and suction. patients in the control group, placebo (tablet B6) will be used vaginally before surgery and the amount of bleeding during the operation will be measured by measuring gas and blood clots and suction. Reduce vaginal bleeding. Timepoint: During surgery and 6 hours after surgery. Method of measurement: Based on suction and gas and long gas. Decreased transfusion of blood products. Timepoint: 6 hours after surgery. Method of measurement: Measurement of hemoglobin. Gorgan University of Medical Sciences Approved 2021-12-04 Ethics Committee of Golestan University of Medical Sciences Sayad Shirazi Street, Sayad Shirazi Hospital GORGAN Golestan Iran (Islamic Republic of)