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Purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean section with one or more risk factor for postpartum hemorrhage.
Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries. The risk of PPH is much higher for women undergoing cesarean delivery (CD). Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a single-dose injection; intravenously administered carbetocin has a half-life of approximately 40 min.
A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection.
The aim of this study is to compare the effectiveness of combined tranexamic acid (TA) and oxytocin infusion with intravenous carbetocin for prevention of PPH in patients with risk factors during cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbetocin plus placebo to TA and placebo to oxytocin | Active Comparator | 100 μg carbetocin ampoule or separate placebo ampoule was diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby plus two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion |
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| oxytocin plus TA | Active Comparator | 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 1gm TA in 100ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby |
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| oxytocin plus placebo to TA and placebo to carbetocin | Active Comparator | 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbetocin | Drug | 100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby |
| Measure | Description | Time Frame |
|---|---|---|
| The number of the patient need of additional pharmacological uterotonic. | calculate the number of the patient need of additional pharmacological uterotonic. | 24 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| estimation of intraoperative blood loss (ml) | measure Intraoperative blood loss in ml by gravimetric methods | during the operation |
| amount of postoperative blood loss | measure amount of blood loss post operative in ml by gravimetric methods |
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Inclusion Criteria:
Exclusion Criteria:
Women who undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University | Recruiting | Aswān | 81528 | Egypt |
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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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A Double-Blind Randomized Clinical Trial
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A Double-Blind Randomized Clinical Trial
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| oxytocin | Drug | 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby |
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| TA | Drug | 2 ampoules of TA in 100 ml saline by slow infusion |
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| placebo to carbetocin | Drug | placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby |
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| placebo to TA | Drug | 2 placebo ampoules to TA in 100 ml saline by slow infusion |
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| placebo to oxytocin | Drug | two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby |
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| 24 hours post operative |
| number of patient with postpartum hemorrhage | calculation of the number of the patients with blood loss >1000 ml | 24 hours post operative |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |