- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02044549
Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 12151
- Ahmed Maged
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All participants are at 37 - 40 weeks of gestational age
- Noncomplicated pregnancy.
Exclusion Criteria:
- Participants with placenta previa
- Patients with coagulopathy
- preeclamptic women
- known sensitivity to oxytocin or methergine were excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: carbetocin
single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal.
|
Oxycontin analogue
Other Names:
|
Active Comparator: Syntometrine
Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
|
Uterotonins
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevention of post partum hemorrhage after CS
Time Frame: 24 hours
|
Number of participants experienced postpartum hemorrhage
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
side effects of drugs used
Time Frame: 24 hours
|
Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed Maged, MD, Ass prof kasr aini medical school
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Carbitocin
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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