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Study aim
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Determining the effectiveness of prophylactic administration of fibrinogen in reducing bleeding during cesarean section
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized with dice tose, phase 2 on 105 patients.
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Settings and conduct
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After obtaining informed consent, all candidates for elective cesarean section in the operating room of Imam Hossein Hospital in Tehran, patients with uncontrolled underlying disease, previous surgical history in the current operation field, substance abuse, and recent history of coagulation disease or use of anticoagulants prior to hospitalization will be excluded from the study. In the fibrinogen group, patients receive 1 gram of this drug in 50 ml of distilled water through an infusion pump over ten minutes. In the control group, 50 ml of distilled water will be used in the same way as above. An anesthesia technician selects one of the syringes containing fibrinogen or placebo for the patient without informing the anesthesiologist and the patient. The questionnaire is delivered to the first technician.
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Participants/Inclusion and exclusion criteria
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All candidates for an elective cesarean section are examined in the operating room at Imam Hossein Hospital in Tehran after obtaining their informed consent. Individuals with uncontrolled underlying disease, a history of prior surgery in the current surgical area, drug use, and a recent history of coagulation disease or use of anticoagulants prior to hospitalization will be excluded.
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Intervention groups
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In the fibrinogen group (case), patients will receive one gram of this drug in a volume of 50 ml of distilled water through an infusion pump within ten minutes of intravenous injection. In the control group, 50 ml of distilled water will be used in the same way as above.
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Main outcome variables
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Bleeding during surgery Postoperative bleeding