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IRCT20100429003833N2 IRCT 2021-10-02 Vice chancellor for Research,Tabriz University Of Medical Sciences Comparison of the effects of misoprostol and oxytocine on postpartum Hemorrhage Comparison of the effects of misoprostol and oxytocine on postpartum Hemorrhage 2021-10-23 anticipated 237 Complete https://irct.ir/trial/57676 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be divided into three groups using a table of random numbers. This table contains the numbers 1 to 237 irregularly and without a specific pattern. To prepare this table, the site https://www.Randomization.com will be used. Numbers will be read by default (up, down, left or right). Then, the numbers 0-90 will be considered for group A, the numbers 91-181 for group B and the numbers 182-273 for group C. For concealment, opaque and sealed envelopes will be used. Each number will be written on a card and the cards will be placed inside the envelopes. When a patient enters the study, one of the envelopes is opened and the assigned group of that patient is revealed, Blinding description: Sequences of the intervention groups will be provided for the operating room in matte envelopes, and When the cesarean section is started, it will be opened by the nurse cooperating in the study. Each group will be treated according to a specific treatment protocol. All participants and surgeons will be unaware of the grouping of the participants before the time of the intervention. 2 Postpartum hemorrhage. Intervention 1: Intervention group 1: Oxytocin 10 units (inside 500 cc of Ringer's serum) and sublingual misoprostol tablets of 400 micrograms (after placental abruption and uterine correction are inserted in the patient's sublingual and controlled by anesthesia technician to prevent suffocation.). Intervention 2: Intervention group 2: Oxytocin recipient 10 units (inside 500 cc of Ringer serum) and intrauterine misoprostol tablet of 400 micrograms (after placental abruption and uterine correction, it is inserted in two uterine poles - 200 micrograms in each cornea). Intervention 3: Intervention group 3: Oxytocin receptor 30 units (within 500 cc of Ringer serum). 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 After the completion of the project, the decision will be made.
public Vahideh Rahmani
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 35519161 lahroudin@gmail.com Tabriz University of Medical Sciences scientific Vahideh Rahmani
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 004135539161 lahroudin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) singleton pregnant women elective cesarean delivery Maximum history of once cesarean section 18 years 40 years Female Preeclampsia Cardiovascular diseases Uterine myoma A history of excessive bleeding after delivery. Underlying disease, such as coagulopathy Abnormal placental implantation (Placenta peria or Ecrta) 072.1 Other immediate postpartum haemorrhage Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Oxytocin 10 units (inside 500 cc of Ringer's serum) and sublingual misoprostol tablets of 400 micrograms (after placental abruption and uterine correction are inserted in the patient's sublingual and controlled by anesthesia technician to prevent suffocation.) Intervention group 2: Oxytocin recipient 10 units (inside 500 cc of Ringer serum) and intrauterine misoprostol tablet of 400 micrograms (after placental abruption and uterine correction, it is inserted in two uterine poles - 200 micrograms in each cornea) Intervention group 3: Oxytocin receptor 30 units (within 500 cc of Ringer serum) Bleeding volume during cesarean section. Timepoint: After the placenta is removed until the uterus is repaired. Method of measurement: Number of gases and lumps of wet gases and volume of blood in suction. Bleeding volume during the first 24 hours of cesarean section. Timepoint: Hemoglobin and hematocrit are measured 24 hours after surgery and compared with preoperative values. Method of measurement: blood test. Duration of surgery. Timepoint: From the start of surgery to complete repair of the uterus. Method of measurement: Record start and end times. Drug side effects. Timepoint: From the time of hospitalization to the patient's discharge. Method of measurement: Control vital signs. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2021-08-02 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)