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IRCT20140420017365N5 IRCT 2025-07-27 Oroumia University of Medical Sciences Investigation of the effects of carbetocin versus oxytocin in preventing postpartum hemorrhage Investigation of the effects of carbetocin versus oxytocin in preventing postpartum hemorrhage in patientsundergoing elective cesarean sections 2025-08-06 anticipated 184 Complete https://irct.ir/trial/85037 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be carried out using the convenience sampling method among patients who are candidates for elective cesarean section and do not meet any of the exclusion criteria. Random allocation to the study groups will be performed using the permuted block randomization method in two groups with a block size of four (Sealed Envelope: 65871875657749). The randomization process will be based on a pre-designed Excel file corresponding to the determined sample size. A total of 46 blocks of four will be generated, each containing two assignments to Group A and two to Group B in varying sequences (e.g., BBAA). Each patient within a block will be assigned a unique identification code, which will be known only to the clinical evaluator responsible for assessing patient outcomes. This code will be recorded on the patient's data collection form. At the time of enrollment, patients will only be assigned the unique code. The intervention group will be revealed at the time of drug administration by the clinical evaluator, who will determine which of the two study drugs the patient will receive, Blinding description: Allocation to the study groups will be performed randomly using the permuted block method in two groups with a block size of 4 (Sealed Envelope: 65871875657749). Random allocation will be done using a pre-designed Excel file based on the calculated sample size. A total of 46 blocks, each consisting of 4 allocations (with two assignments to group A and two to group B, e.g., BBAA), will be used. Each patient within a block will be assigned a unique identification code. This code will only be known to the clinical evaluator and will be recorded in the patient data collection form. Upon entry into the study, only this unique code will be assigned to the patient. The intervention group (i.e., the medication to be administered) will then be revealed at the time of drug administration by the evaluator who is aware of the allocation. Patients will remain blinded to the group assignments. In the random sampling process, each patient will be assigned a unique code that will be kept confidential. As described in the sampling and randomization method, each block and group assignment is associated with a unique code indicating the group. In this way, patients will receive only the code at study entry, and the assigned intervention will be determined at the appropriate time by the clinical evaluator. 3 Blood loss after cesarean. Intervention 1: Intervention group: Intervention Group A (Carbetocin Group):In the carbetocin group, to minimize the risk of hypotension caused by spinal anesthesia, all patients will receive an infusion of 500 mL of 0.9% normal saline prior to the start of surgery. Blood pressure and heart rate will be checked and recorded before drug administration. Following placental delivery, 100 micrograms of intravenous carbetocin will be administered. After drug administration, blood pressure and heart rate will be monitored every 10 minutes for two times, followed by every 30 minutes for two times, and then every 30 minutes for up to two hours. Vital signs will be measured automatically using a pulse oximetry device, and the recorded data will be entered into patient data collection forms by the principal investigator. Intervention 2: Intervention group: Intervention Group B (Oxytocin Group):In the oxytocin group, following placental delivery, an intravenous infusion of 30 units of oxytocin in 1 liter of 0.9% normal saline will be initiated and administered over 2 hours while the patient remains in the operating room and recovery area. After transfer to the ward, an additional 20 units of oxytocin will be infused over a period of 8 hours. Following drug administration, blood pressure and heart rate will be monitored every 10 minutes for two times, followed by every 30 minutes for two times, and then every 30 minutes for up to two hours. Vital signs will be automatically measured using a pulse oximeter device, and all recorded parameters will be entered into the patient data collection forms by the principal investigator. Yes - There is a plan to make this available What will be shared: non-demographic data files , including the main study variables ,are published online in excel format. When: The data will be published after the publication of the protocol paper and the original paper of the study results by the corresponding researcher. To whom: The data will be available online without any request. Conditions: For analysis and study by other interested researchers. Where to obtain: The data will be available online. How to obtain: The data will be available online without any request. Comments:
public Horiyeh Gasempoursore
Kowsar Hospital, Hasani streat , Urmia
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 0998 horiya.gsmp93@gmail.com Oroumia University of Medical Sciences scientific Elnaz Afsari
Kowsar Hospital, Hasani streat , Urmia
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 0998 dr.afsari۹۹@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) All patients who are candidates for elective cesarean section , including nulliparous women , breech presentations , and those with a history of one previous cesarean , provided that they have signed an informed written consent. 18 years 45 years Female diabetes hypertension multiple pregnancy polyhydramnios macrosomia kidney , heart and liver diseases Maternal coagulation disorders placental attachment disorders (accreta , increta and percreta) O72 Postpartum hemorrhage Prevention Prevention Intervention group: Intervention Group A (Carbetocin Group):In the carbetocin group, to minimize the risk of hypotension caused by spinal anesthesia, all patients will receive an infusion of 500 mL of 0.9% normal saline prior to the start of surgery. Blood pressure and heart rate will be checked and recorded before drug administration. Following placental delivery, 100 micrograms of intravenous carbetocin will be administered. After drug administration, blood pressure and heart rate will be monitored every 10 minutes for two times, followed by every 30 minutes for two times, and then every 30 minutes for up to two hours. Vital signs will be measured automatically using a pulse oximetry device, and the recorded data will be entered into patient data collection forms by the principal investigator. Intervention group: Intervention Group B (Oxytocin Group):In the oxytocin group, following placental delivery, an intravenous infusion of 30 units of oxytocin in 1 liter of 0.9% normal saline will be initiated and administered over 2 hours while the patient remains in the operating room and recovery area. After transfer to the ward, an additional 20 units of oxytocin will be infused over a period of 8 hours. Following drug administration, blood pressure and heart rate will be monitored every 10 minutes for two times, followed by every 30 minutes for two times, and then every 30 minutes for up to two hours. Vital signs will be automatically measured using a pulse oximeter device, and all recorded parameters will be entered into the patient data collection forms by the principal investigator. Intraoperative blood loss. Timepoint: from placental delivery to uterine suturing. Method of measurement: Measurement of Blood Loss: Blood volume will be measured by recording the amount collected in the suction device and weighing all surgical gauzes and laparotomy sponges before and after surgery. A non-absorbent plastic sheet will be placed at the beginning of the procedure, and all pre-weighed materials will be collected on it. After surgery, the materials will be reweighed. The difference in weight (in grams) will be recorded, with each gram considered equivalent to 1 mL of blood loss. Postoperative blood loss during the first 2 hours after cesarean section. Timepoint: during the first 2 hours after cesarean section. Method of measurement: Blood Volume and Blood Loss Estimation:The blood volume in non-pregnant women is calculated using the following formula:Blood volume (mL) = (50 × height in inches) + (25 × weight in pounds) / 2In pregnancy, blood volume increases by approximately 30–60% (about 1500–2000 mL) in women with average body size and no hypovolemia.During delivery, pregnant women can typically tolerate blood loss nearly equal to this additional volume without a significant drop in hematocrit.If blood loss is less than the pregnancy-induced blood volume increase, hematocrit remains stable in the acute phase and for the first few days postpartum.However, if the postpartum hematocrit is lower than the admission hematocrit, the estimated blood loss corresponds to the amount of volume lost, with every 500 mL of blood loss resulting in approximately a 3% decrease in blood volume.In this study, blood loss for each patient will be estimated using the difference between pre-delivery and 24-hour postpartum hematocrit levels. Need for blood product transfusion within 48 hours post-surgery. Timepoint: within 48 hours post-surgery. Method of measurement: The requirements for transfusion of packed cells (P.C), fresh frozen plasma (FFP), and platelets will be documented within 48 hours following the surgical procedure. Changes in hemoglobin level. Timepoint: within 48 hours postpartum. Method of measurement: Hemoglobin levels will be assessed at baseline (on the day of admission before surgery) and at 6-hour intervals up to 48 hours postpartum in both groups receiving oxytocin and carbetocin. Changes in hematocrit levels. Timepoint: within 48 hours postpartum. Method of measurement: Hematocrit levels will be evaluated at baseline (on the day of admission before the procedure) and at 6-hour intervals up to 48 hours postpartum in both groups receiving oxytocin and carbetocin. Patients vital signs. Timepoint: before the intervention, then every 10 minutes for two times, followed by every 30 minutes for two times, and subsequently every 30 minutes for up to two hours. Method of measurement: Patients' vital signs — including heart rate, systolic blood pressure, diastolic blood pressure, and body temperature — will be recorded before the intervention, then every 10 minutes for two times, followed by every 30 minutes for two times, and subsequently every 30 minutes for up to two hours. Blood pressure and heart rate will be continuously monitored and documented. Need for hemorrhage control. Timepoint: within 48 hours postpartum. Method of measurement: The indications for administration of anticoagulant drugs and/or surgical interventions will be evaluated within 48 hours postpartum. Adverse drug effects. Timepoint: first 6 hours after surgery. Method of measurement: The incidence of headache, fever, chills, nausea, and vomiting will be assessed in all patients during the first 6 hours after surgery. Oroumia University of Medical Sciences Approved 2025-06-25 Ethics committee of Urmia University of Medical Sciences Urgent Street , Resalat Blvd , Urmia , Iran urmia West Azarbaijan Iran (Islamic Republic of)