Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Carbetocin
Oxytocin
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Postpartum Hemorrhage, carbetocin, oxytocin
Eligibility Criteria
Inclusion Criteria:
- Multiple pregnancy
- Presence of uterine fibroid
- Previous Myomectomy
- Presence of placenta previa
- Past History of PPH
- Fetal Macrosomia
- Polyhydramnios
Exclusion Criteria:
- Hypertension
- Preeclampsia
- Cardiac, Renal, Liver diseases
- Epilepsy
- History of hypersensitivity to Carbetocin
Sites / Locations
- Ghamra Military Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Carbetocin arm
oxytocin arm
Arm Description
100 μg intravenous injection at delivery of the anterior shoulder
5 IU intravenous injection at delivery of the anterior shoulder
Outcomes
Primary Outcome Measures
amount of blood loss
Secondary Outcome Measures
need for another uterotonic medication
after administration of Carbetocin or Oxytocin
need for blood transfusion or operative intervention
Full Information
NCT ID
NCT02391636
First Posted
February 17, 2015
Last Updated
January 24, 2017
Sponsor
Ghamra Military Hospital
Collaborators
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02391636
Brief Title
Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage
Official Title
Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ghamra Military Hospital
Collaborators
Ain Shams Maternity Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Postpartum Hemorrhage, carbetocin, oxytocin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbetocin arm
Arm Type
Experimental
Arm Description
100 μg intravenous injection at delivery of the anterior shoulder
Arm Title
oxytocin arm
Arm Type
Active Comparator
Arm Description
5 IU intravenous injection at delivery of the anterior shoulder
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Pabal
Intervention Description
at delivery of anterior shoulder
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
at delivery of anterior shoulder
Primary Outcome Measure Information:
Title
amount of blood loss
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
need for another uterotonic medication
Description
after administration of Carbetocin or Oxytocin
Time Frame
5 minutes
Title
need for blood transfusion or operative intervention
Time Frame
during surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Multiple pregnancy
Presence of uterine fibroid
Previous Myomectomy
Presence of placenta previa
Past History of PPH
Fetal Macrosomia
Polyhydramnios
Exclusion Criteria:
Hypertension
Preeclampsia
Cardiac, Renal, Liver diseases
Epilepsy
History of hypersensitivity to Carbetocin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maged M El.Sherif
Organizational Affiliation
Ghamra Military Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghamra Military Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage
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