Study procedure
thrombosis, bleeding, fever, blood loss, hemorrhage
THROMBOSIS, BLEEDING, BLOOD LOSS, WOUND INFECTION, UTERUS, HEMORRHAGE, SECONDARY, ADHESION, COMPLICATIONS
The eligible women were randomized by a simple randomization table generated by computer software and were allocated using sealed opaque envelopes into three parallel groups: (1) the first group received 30 IU of oxytocin infused in 500 ml normal saline administered during CS with two ampules of distilled water before skin incision by the intravenous route which had the same color and shape of ethamsylate and tranexamic acid, (2) the second group received both tranexamic acid and ethamsylate once before skin incision by the intravenous route with an ampule of distilled water infused in 500 ml normal saline which had the same shape and color of oxytocin during CS; one gram of tranexamic acid (two ampoules of Kapron 500 mg) and 250 mg of ethamsylate (one ampoule of dicynone), and (3) the third group received one ampule of distilled water during CS infused in 500 ml saline with two ampoules of distilled water before skin incision by intravenous route. Nurses were responsible to administer the drugs during the operation. All patients were blinded to the administered drug. In case of failure to stop bleeding, methergine, oxytocin, or both were additionally administered. Then, B-lynch suture or internal iliac ligation were performed in case of failed oxytocin plus methergine. Finally, a hysterectomy procedure was done to control the failed cases.The surgeons were blinded from the selected drug and classically performed the lower segment CS. The anesthesia method of choice was spinal anesthesia. At the end of the operation, the uterus was sutured into two layers then the incision is closed. The investigators always blindly monitored the patients' vital signs like heart rate, blood pressure, urine output, and uterine contractility.The main outcome was measuring the amount of bleeding during surgery by placing the towels, weighing them, and then subtracting the weight of dry towels from the wet ones to know the blood loss amount. The secondary outcomes were: 1) operation time; 2) hospital stay; 3) difference in hemoglobin and hematocrit values after 24 h; 4) the need for blood transfusion during surgery and in the first 24 h after surgery; 5) post-operative complications like hemorrhage, thrombosis, fever, intra-operative adhesion, and wound infection; and 6) the need for other procedure to control bleeding. All outcome assessors were blinded to each group.