Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02391636|
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : January 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Drug: Carbetocin Drug: Oxytocin||Phase 4|
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 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.
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.
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.
- The hemodynamic adverse effects and the cost-benefit of both drugs.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Carbetocin arm
100 μg intravenous injection at delivery of the anterior shoulder
at delivery of anterior shoulder
Other Name: Pabal
Active Comparator: oxytocin arm
5 IU intravenous injection at delivery of the anterior shoulder
at delivery of anterior shoulder
Other Name: Syntocinon
- amount of blood loss [ Time Frame: 24 hours ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391636
|Ghamra Military Hospital|
|Principal Investigator:||Maged M El.Sherif||Ghamra Military Hospital|