Clinical Trial: Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial
Brief Summary: Double blinded randomized controlled study
Detailed Summary:
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:
-
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 uterot
Sponsor: Ghamra Military Hospital
Current Primary Outcome: amount of blood loss [ Time Frame: 24 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- need for another uterotonic medication [ Time Frame: 5 minutes ]after administration of Carbetocin or Oxytocin
- need for blood transfusion or operative intervention [ Time Frame: during surgery ]
Original Secondary Outcome: Same as current
Information By: Ghamra Military Hospital
Dates:
Date Received: February 17, 2015
Date Started: February 2015
Date Completion:
Last Updated: January 24, 2017
Last Verified: January 2017
- need for another uterotonic medication [ Time Frame: 5 minutes ]