NCT02391636

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

Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Ghamra Military Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Double blinded randomized controlled study

Detailed description

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

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Carbetocin	at delivery of anterior shoulder
DRUG	Oxytocin	at delivery of anterior shoulder

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2015-03-18
• Last updated: 2017-01-25

Locations

1 site across 1 country: Egypt