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| Name | Class |
|---|---|
| Ain Shams Maternity Hospital | OTHER |
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Double blinded randomized controlled study
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbetocin arm | Experimental | 100 μg intravenous injection at delivery of the anterior shoulder |
|
| oxytocin arm | Active Comparator | 5 IU intravenous injection at delivery of the anterior shoulder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbetocin | Drug | at delivery of anterior shoulder |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| amount of blood loss | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| need for another uterotonic medication | after administration of Carbetocin or Oxytocin | 5 minutes |
| need for blood transfusion or operative intervention | during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maged M El.Sherif | Ghamra Military Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghamra Military Hospital | Cairo | Cairo Governorate | 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 |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Oxytocin | Drug | at delivery of anterior shoulder |
|
|
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |