]>
IRCT20080826001096N5 IRCT 2018-04-26 Guilan University of Medical Sciences rectal misoprostol on intraoperative blood loss prior to abdominal myomectomy. Evaluating the effects of rectal misoprostol prior to myomectomy on the volume of hemorrhage in versus of placebo in al Zahra hospital patients with intramural myoma from 2017-2018 2018-04-21 anticipated 94 Complete https://irct.ir/trial/28238 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A randomized random blocking technique in one of the 4 blocks (aabb, abab, baba, bbaa) is divided into two groups receiving placebo, receiving misoprostol, by Skilled trained technician. The hemoglobin is measured and recorded before surgery in the laboratory. To be blinded, Misoprostol (Miso Glendine, Sami Mus) with a dose of 400 micrograms of rectal one hour before surgery by the head nurse of the electrocardiogram section, the midwife of the collaborator, who is not a research team, is placed in the patient. In the control group, a placebo tablet of the shape and size They are similar to misoprostol but contain inert material. All collected data is documented and recorded in hospital records. All surgical procedures are performed by the Fanstile cut.Numerical comparison and filling out all of the above information, separately and Double blind, are carried out by two gynecologic assistants, Blinding description: The participants in the study and the person who evaluated the outcome of the pain (second operator) do not know the nature of the codes (double blind study). 3 myoma. Intervention 1: Intervention group: 2 pills equal to 400 mcg misoprostol will be placed rectal one hour before the surgery. Intervention 2: Control group: 2 pills vitamin B6 will be placed rectal one hour before the surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is still planning to share and publish.
public Fatemeh Hosseini
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839 -41446 +98 13 3336 9224 f_hoseini@gums.ac.ir Guilan university of Medical Sciences scientific Dr. Seyedeh Hajar Sharami
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839 -41446 +98 13 3336 9224 sharami@gums.ac.ir Guilan University of Medical Sciences Iran (Islamic Republic of) age between 18-50 years 5 or less symptomatic myoma intramoral myoma based on sonography A minimum of 4 cm in size of myoma (because no smaller than 4 cm can produce a lot of bleeding) 18 years 50 years Female anemia (HB less than10) allergy to Misoprostol (By asking questions such as skin sign, hives, rash, shortness of breath, coughing, chest pain after the previous use of Miso Prostol) Cardiopulmonary diseases Hemorrhage disorders obese (Body Mass Index more than35) Uncontrolled blood pressure despite drug use uterine size more than 24 weeks D25 Leiomyoma of uterus Treatment - Drugs Placebo Intervention group: 2 pills equal to 400 mcg misoprostol will be placed rectal one hour before the surgery. Control group: 2 pills vitamin B6 will be placed rectal one hour before the surgery Length of stay in hospital. Timepoint: From admission to exit. Method of measurement: day. Postoperative hemoglobin and hematocrit. Timepoint: 4 and 24 hours after surgery. Method of measurement: blood test. Blood loss. Timepoint: Intraoperative and postoperative. Method of measurement: On hemoglobin level and Severity of bleeding Total blood volume in the suction bottle + wet gauze and long gauze. Guilan University of Medical Sciences Approved 2017-09-23 • Ethics committee of Guilan University of Medical Sciences Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, IRAN Rasht Guilan Iran (Islamic Republic of)