Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section
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|ClinicalTrials.gov Identifier: NCT02044549|
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : January 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage Blood Loss||Drug: carbetocin Drug: Syntometrine||Phase 4|
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 :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Active Comparator: carbetocin
single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal.
Other Name: Pabal
Active Comparator: Syntometrine
Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
Other Name: Oxytocin methergine combination
- prevention of post partum hemorrhage after CS [ Time Frame: 24 hours ]Number of participants experienced postpartum hemorrhage
- 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
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): NCT02044549
|Cairo, Egypt, 12151|
|Principal Investigator:||Ahmed Maged, MD||Ass prof kasr aini medical school|