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Study aim
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Evaluation of the effectiveness of sub-endometrial injection of vasopressin for the postpartum bleeding in patients with placental accreta
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Design
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Two-arm parallel group double blinded randomized trial, phase 3 for 60 patients, randomized by envelopes
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Settings and conduct
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After providing sufficient explanations and obtaining informed consent in Imam Khomeini hospital complex, Tehran, , the patients' initial data will be collected, and a distinct date for cesarean section will be determined. Participants will then be randomly assigned into intervention or control groups. For patients, ready-to-inject solutions are provided by the hospital pharmacy. The prepared solution for the intervention group is 20 ml in total, containing 1 ml of vasopressin, equivalent to 5 units, which is diluted in 19 ml of 0.9% normal saline. The solution prepared for the control group will also contain 20 ml of 0.9% normal saline. The only person who knows the contents of the solution is the pharmacist, and doctors do not know the contents of the syringes during the operation. After the intervention, the health care personnel will be also blinded.
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Participants/Inclusion and exclusion criteria
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Pregnant women with more than18 years of age, with diagnosis of placenta accarta according to ultrasound findings by a radiologist
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Intervention groups
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For the intervention group, a total of 20 ml, containing 1 ml of vasopressin, equivalent to 5 units, diluted in 19 ml of normal saline 0.9% will be injected. The solution prepared for the control group will also contain 20 ml of 0.9% normal saline.
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Main outcome variables
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Hemoglobin level before Cesarean Section, Hemoglobin level after Cesarean Section, Blood transfusion