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:

  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 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