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IRCT20200501047257N1 IRCT 2020-05-18 Mazandaran University of Medical Sciences Evaluation of the effect of misoprostol on cesarean bleeding Comparison of the effect of sublingual mesoprostol, rectal and venous oxytocin on cesarean uterine bleeding 2020-05-10 anticipated 180 Complete https://irct.ir/trial/47720 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To allocate groups via permutation block randomization will be used, patients in the study using the blocks 6 each using the letters A, B, and C (for equality groups), the patients into 3 groups of 6 people divided . For permutation block randomization method of sealed envelopes with random sequences will be used, Blinding description: In this study, blindness is performed for statistical counselors as statistical counselors are not aware of the type of data they perform for analysis and only the data are identified by three groups A, B and C, and they are named by groups. And the method of intervention is unknown. 3 The amount of bleeding from a cesarean section. Intervention 1: First intervention group: After umbilical cord clamping during surgery, the patient will receive 20 oxytocin units within half a liter of Ringer's serum at a rate of 15 cc per minute.In the first intervention group, we place 200 micrograms of misoprostol in the patient's sublingual (It should be noted that Mizoprostol 100 mg tablets are from Abu Reihan Company and 10 units of Oxytocin ampoules are from Alborz Daroo Company).  If proper uterine contraction does not occur after a few minutes (maximum 5 minutes), if the initial intervention is not enough, oxytocin will be repeated up to 100 units (inside the Ringer's serum) and if we need more medication, misoprostol. We continue up to 1000 micrograms. Intervention 2: Second intervention group: After umbilical cord clamping during surgery, the patient will receive 20 oxytocin units within half a liter of Ringer's serum at a rate of 15 cc per minute.In the second intervention group, we place 200 micrograms of misoprostol in the patient's rectal area (It should be noted that Mizoprostol 100 mg tablets are from Abu Reihan Company and 10 units of Oxytocin ampoules are from Alborz Daroo Company). If proper uterine contraction does not occur after a few minutes (maximum 5 minutes), if the initial intervention is not enough, oxytocin will be repeated up to 100 units (inside the Ringer's serum) and if we need more medication, misoprostol. We continue up to 1000 micrograms. Intervention 3: Control group: After umbilical cord clamping during surgery, the patient will receive 20 oxytocin units within half a liter of Ringer's serum at a rate of 15 cc per minute(It should be noted that the oxytocin ampoule is 10 units from Alborz Daroo Co.) . If proper uterine contraction does not occur after a few minutes (maximum 5 minutes), oxytocin is repeated for up to 100 units (inside the Ringer's 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 The data has not yet been determined
public Fatemeh Zahra Bagheri
Gorgan Jadid First Street, 1st Alley, in front of Rosta Complex, two-storey private house
Gorgan Iran (Islamic Republic of) 4913714861 +98 17 3223 3381 bagheri.z1994@gmail.com Mazandaran University of Medical Sciences scientific Hooshang Akbari
Sari, Imam Square, Joibar Three Ways, at the beginning of Valiasr Highway, Central Headquarters of Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4000 hooshangakbari48@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients between the ages of 18 and 40 Candidates for cesarean section Gestational age between 37 and 40 weeks Candidates for Spinal anesthesia Written consent from the patient Single pregnancy Low transverse uterine incision 18 years 40 years Female History of PPH (postpartum hemorrhage) Placenta previa and acarta Liver or kidney disease Eclampsia and preeclampsia Epilepsy Height below 155 cm Obesity (BMI> 40) ( BMI = Body mass index) Infant weight over 4 kg Polyhydramnios (increased amniotic fluid) Patients received Anti-coagulation drugs Patients with heart and lung problems and underlying diseases such as diabetes, high blood pressure (140/90 mm Hg), chronic anemia, coagulation disorders and immunodeficiency Treatment - Surgery Treatment - Surgery Treatment - Surgery First intervention group: After umbilical cord clamping during surgery, the patient will receive 20 oxytocin units within half a liter of Ringer's serum at a rate of 15 cc per minute.In the first intervention group, we place 200 micrograms of misoprostol in the patient's sublingual (It should be noted that Mizoprostol 100 mg tablets are from Abu Reihan Company and 10 units of Oxytocin ampoules are from Alborz Daroo Company).  If proper uterine contraction does not occur after a few minutes (maximum 5 minutes), if the initial intervention is not enough, oxytocin will be repeated up to 100 units (inside the Ringer's serum) and if we need more medication, misoprostol. We continue up to 1000 micrograms Second intervention group: After umbilical cord clamping during surgery, the patient will receive 20 oxytocin units within half a liter of Ringer's serum at a rate of 15 cc per minute.In the second intervention group, we place 200 micrograms of misoprostol in the patient's rectal area (It should be noted that Mizoprostol 100 mg tablets are from Abu Reihan Company and 10 units of Oxytocin ampoules are from Alborz Daroo Company). If proper uterine contraction does not occur after a few minutes (maximum 5 minutes), if the initial intervention is not enough, oxytocin will be repeated up to 100 units (inside the Ringer's serum) and if we need more medication, misoprostol. We continue up to 1000 micrograms Control group: After umbilical cord clamping during surgery, the patient will receive 20 oxytocin units within half a liter of Ringer's serum at a rate of 15 cc per minute(It should be noted that the oxytocin ampoule is 10 units from Alborz Daroo Co.) . If proper uterine contraction does not occur after a few minutes (maximum 5 minutes), oxytocin is repeated for up to 100 units (inside the Ringer's serum). Bleeding during cesarean section. Timepoint: Bleeding is removed during surgery and after surgery. Method of measurement: The amount of blood lost in each group at the end of the operation, based on the amount of blood in the suction and the estimated blood volume absorbed by each gauze and long gauze with the scales before and after The operation is weighed and the amount of clot excreted from the vagina after uterine massage is calculated at the end of the operation and will be recorded in the desired checklist. Mazandaran University of Medical Sciences Approved 2020-04-29 Ethics Committee of Mazandaran University of Medical Sciences Sari, Farahabad Road, Mazandaran University of Medical Sciences, School of Paramedical Sciences Sari Mazandaran Iran (Islamic Republic of)