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to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section
A double-blind randomized study conducted on 1200 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (600 women) or combination of 5 IU oxytocin and 0.5 mg ergometrine (600 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbetocin | Experimental | 600 women received single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK). |
|
| Syntometrine | Active Comparator | 600 women received one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 micrograms of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbetocin | Drug | single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK). |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postpartum hemorrhage after CS | Number of participants experienced massive postpartum hemorrhage | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| side effects of drugs used | GIT side effects as nausea , vomiting | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AHMED SAMY, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine Cairo university | Giza | 11231 | Egypt |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C020731 | carbetocin |
| C038346 | syntometrine |
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| Syntometrine | Drug | one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 microgram of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes |
|
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |