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Postpartum hemorrhage is the most important cause of maternal morbidity and mortality worldwide and accounts for approximately 25% of deaths worldwide. Drugs such as oxytocin, carbetocin and tranexamic acid are used for bleeding control after normal vaginal delivery. The most widely used agent for the prevention of postpartum hemorrhage worldwide is oxytocin. The primary aim of this study is to reduce the mean blood loss after vaginal delivery. In this study, investigators aimed to compare the efficacy of carbetocin alone in the 1st group, oxytocin alone in the 2nd group, carbetocin and tranexamic acid in the 3rd group, and oxytocin and tranexamic acid in the 4th group in preventing postpartum blood loss originating from the uterus.
This prospective, randomized controlled study was conducted at the Department of Obstetrics and Gynecology of Bezmialem University Hospital and Van Regional Training and Research Hospital between August 2022 and February 2023. The study protocol was approved by the Ethical Committee of the Medical Faculty of Bezmialem University. Written informed consent was obtained from all patients. Investigators included a total of 272 women between 18 and 40 years of age who came to hospital for vaginal delivery at term single pregnancy. This trial was designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
The patients included in this study were randomly divided into four groups by random allocation using a computer-generated random number. Group I: carbetocin (Pabal®; Ferring Pharma, Istanbul, Turkey) (n = 68 )(was intravenously administered immediately after birth of the baby). Group II: Oxytocin(Synpitan forte®; Deva Pharma, Istanbul, Turkey) (n =68)(the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord) Group III: carbetocin and tranexamic acid (Transamin; TEVA Pharma, Istanbul, Turkey)2 (n =68) (100-mg carbetocin was intravenously administered immediately after birth of the baby and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of normal 0.9 % sodium chloride solution was administered immediately after clamping the umbilical cord) . Group IV: oxytocin and tranexamic acid (n=68) (the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of normal 0.9 % sodium chloride solution was administered immediately after clamping the umbilical cord).The collected data were age, prepregnancy body mass index (BMI), gravida, parity, gestational age at birth, Apgar scores at 1 and 5 min, birth weight, neonatal intensive care unit (NICU) admission, the prepartum hemoglobin and hematocrit concentrations, the change in the hemoglobin and hematocrit concentrations (difference between prepartum and postpartum levels), duration of delivery stages, intrapartum blood loss and estimated blood loss after 2 hours of vaginal delivery.
In this study, the investigators aimed to compare the efficacy of oxytocin, carbetocin and tranexamic acid in preventing uterine blood loss during vaginal delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbetocin | Experimental | 100-mg carbetocin was intravenously administered immediately after birth of the baby |
|
| Oxytocin Group | Experimental | The oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord |
|
| Carbetocin and Tranexamic acid Group | Experimental | 100-mg carbetocin was intravenously administered immediately after birth of the baby and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of normal 0.9 % sodium chloride solution was administered immediately after clamping the umbilical cord |
|
| Oxytocin and Tranexamic acid Group | Experimental | The oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of normal 0.9 % sodium chloride solution was administered immediately after clamping the umbilical cord |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I.V carbetocin administration | Drug | Group I: carbetocin was intravenously administered immediately after birth of the baby. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemogram status | Postpartum hemogram status | Postpartum 24th hour |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Transfusion | Number of patients needing Blood Transfusion | Postpartum 24th hour |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gurkan Kıran, MD | Bezmialem Vakif University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakif University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21047614 | Result | Grotegut CA, Paglia MJ, Johnson LN, Thames B, James AH. Oxytocin exposure during labor among women with postpartum hemorrhage secondary to uterine atony. Am J Obstet Gynecol. 2011 Jan;204(1):56.e1-6. doi: 10.1016/j.ajog.2010.08.023. Epub 2010 Nov 3. | |
| 5471863 | Result | Chard T, Boyd NR, Forsling ML, McNeilly AS, Landon J. The development of a radioimmunoassay for oxytocin: the extraction of oxytocin from plasma, and its measurement during parturition in human and goat blood. J Endocrinol. 1970 Oct;48(2):223-34. doi: 10.1677/joe.0.0480223. No abstract available. |
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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 |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| I.V Oxytocin administration | Drug | Group II: Oxytocin the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord. |
|
|
| I.V carbetocin and tranexamic acid administration | Drug | Group III: carbetocin and tranexamic acid 100-mg carbetocin was intravenously administered immediately after birth of the baby and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of normal 0.9 % sodium chloride solution was administered immediately after clamping the umbilical cord. |
|
|
| I.V Oxytocin and tranexamic acid administration | Drug | Group IV: oxytocin and tranexamic acid the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of normal 0.9 % sodium chloride solution was administered immediately after clamping the umbilical cord |
|
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| 1623693 | Result | Hunter DJ, Schulz P, Wassenaar W. Effect of carbetocin, a long-acting oxytocin analog on the postpartum uterus. Clin Pharmacol Ther. 1992 Jul;52(1):60-7. doi: 10.1038/clpt.1992.103. |
| 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 |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |