Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage

Overview

Double blinded randomized controlled study

Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST. 264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used. Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous injection at delivery of the anterior shoulder. Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous injection at delivery of the anterior shoulder. * All patients will receive general anaesthesia. * Operation will be carried out by a three year registrar (at least). * Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss. * Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood loss will be calculated using the following equation: * The actual blood loss equals the estimated blood volume X difference between the initial hematocrit and the final hematocrit / the initial hematocrit Secondary endpoints include: 1. The need for additional uterotonic medication after carbetocin or oxytocin administration. \- Uterine tone and Uterine fundus level (with respect to the umbilical point, UP) will be monitored during CS, at the end of CS, 2 hours, 12 hours and 24 hours after delivery \- Additional uterotonic drugs, needed if sufficient uterine tone is not achieved within 5 minutes of oxytocin or carbetocin administration, will include: i. Ergometrine 0.5 mg by slow intravenous injection. ii. Misopristol 1000 micrograms rectally. 2. The need for blood transfusion or operative interventions related to PPH \- The need for blood transfusion or operative intervention (B-Lynch sutures, uterine artery ligation, internal iliac artery ligation, Hysterectomy) will be considered. 3. The change in hemoglobin and hematocrit post versus pre CS \- The drop in hemoglobin level and hematocrit will be evaluated by comparing the hemoglobin concentration on admission and 24 hours after delivery. 4. The hemodynamic adverse effects and the cost-benefit of both drugs.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes