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The cesarean section is a bloody operation, about 750 to 1000 ml are lost at most operations and over 1000 ml of blood have lost to bring them into the definition of a postpartum hemorrhage (PPH). In developing countries, PPH is the main cause of maternal deaths. Uterine atony is the most common cause of immediate heavy PPH.Multiple pregnancy ones of a common factor for uterine atony. The administration of oxytocic's after the delivery of the neonate reduces the likelihood of PPH and 5 IU oxytocin by slow intravenous injection is currently recommended for all cesarean sections. However, the use of additional oxytocic medication is common, to arrest bleeding, or prophylactically if there are risk factors for PPH . Carbetocin is a synthetic analog of human oxytocin with structural modifications that increase its half-life, thereby prolonging its pharmacological effects. Carbetocin has been approved in 23 countries for prevention of uterine atony and excessive bleeding following cesarean delivery in spinal or epidural anesthesia. Oxytocin is a peptide of nine amino acids (Nona peptide). The structure of oxytocin is very similar to that of arginine vasopressin, whose sequence differs from oxytocin by 2 amino acids. The best-known mechanism for oxytocin to exert its stimulatory effect on myometrial contractility is by increasing the intracellular concentration of calcium. Owing to its short plasma half-life (mean 3 min), a continuous intravenous infusion is required to maintain the uterus in a contracted state. The usual dose is 20 IU in 500 ml of crystalloid solution, with the dosage rate adjusted according to response. Ergometrine is a selective and moderately potent tryptaminergic receptor antagonist in various smooth muscles, being only a partially agonistic or antagonistic at tryptaminergic receptors in the central nervous system. In blood vessels, the alkaloid is only weakly antagonistic of dopaminergic receptors and partially agonistic of α-adrenergic receptors. oxytocin (19%). Blood loss>500 ml was only observed in women who received oxytocin. The aim of the investigator's study was to compare the effect of carbetocin vs. oxytocin and ergometrine for prevention of PPH during cesarean section in women with multiple pregnancies.
Women included in the study were divided into 2 groups: Group (A): included patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby. Group (B): included patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and intramuscular ergometrine 0.2 mg. The slow administration has been shown to reduce the potentially harmful hemodynamic effects of oxytocin (and presumably carbetocin). Also, intramuscular injection of ergometrine did the same. All women were subjected to full history taking, general and obstetric examination and investigations in the form of preoperative routine labs and obstetric ultrasound, and postoperative serum hemoglobin %.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbetocin arm | Experimental | carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby |
|
| oxytocin and ergometrine arm | Active Comparator | oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist plus intramuscular ergometrine 0.2 mg after the birth of the baby |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbetocin | Drug | Group (A): included 100 patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby. |
| Measure | Description | Time Frame |
|---|---|---|
| estimation of intraoperative blood loss (ml). | Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and vaginal bleeding | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| need for blood transfusion | need for blood transfusion | 24 hours postoperative |
| Hemoglobin concentration | pre and postoperative hemoglobin estimation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AswanUH | Aswān | 81528 | 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 |
| D004874 | Ergonovine |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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The current study was a single-blinded randomized controlled trial conducted at a tertiary University Hospital Women included in the study were divided into 2 groups: Group (A): included 100 patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after birth of the baby. Group (B): included 100 patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and intramuscular ergometrine 0.2 mg.
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the participants blinded the arms of the study
|
| oxytocin | Drug | Group (B): included 100 patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and |
|
|
| ergometrine | Drug | intramuscular ergometrine 0.2 mg. |
|
|
| ist 24 hours postoperative] |
| 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 |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |