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The aim of this study is to evaluate the renal outcome of patients undergoing elective C/S where oxytocin or carbetocin is used for postpartum hemorrhage prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | This group will be given 3 IU / 3 ml oxytocin (intravenously) after the clamping of the umbilical cord. Uterine tonus will be assessed after 60 seconds and if it is lower than 7, oxytocin 3 IU / 3 ml will be repeated, up to a maximum of three times. If uterine tonus is still lower than 7, rescue uterotonics such as intramuscular methylergonovine or intravenous misoprostol will be administered. |
| |
| Carbetocin | This group will be given 100 mcg / 3 ml carbetocin (intravenously) after the clamping of the umbilical cord. If uterine tonus is lower than 7, rescue uterotonics such as intramuscular methylergonovine or intravenous misoprostol will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | To be given to Oxytocin group following the clamping of the umbilical cord |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urine volume | Total amount of intraoperative urine output in milliliters | Intraoperative period |
| Urinary sodium | The change in urinary sodium content (milligrams) compared to the preoperative period | Preoperative, Postoperative 2nd, 4th, 24th hours |
| Blood sodium | The change in blood sodium content (milligrams) compared to the preoperative period | Preoperative, Postoperative 2nd, 4th, 24th hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood osmolality | The change in blood osmolality compared to the preoperative period | Preoperative, Postoperative 2nd, 4th, 24th hours |
| Blood loss | The total volume of intraoperative blood loss |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of term (gestational age greater than 37 weeks) pregnant women scheduled to undergo elective cesarean section.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gamze S Çağlar, Prof.Dr. | Contact | +903122044000 | gamzesinem@hotmail.com | |
| Baturay K Kazbek, MD | Contact | +903122044000 | bkkazbek@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ufuk University Faculty of Medicine Hospital | Ankara | Balgat | 06510 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23741542 | Background | Larciprete G, Montagnoli C, Frigo M, Panetta V, Todde C, Zuppani B, Centonze C, Bompiani A, Malandrenis I, Cirese A, Valensise H. Carbetocin versus oxytocin in caesarean section with high risk of post-partum haemorrhage. J Prenat Med. 2013 Jan;7(1):12-8. | |
| 9760035 | Background | Engstrom T, Barth T, Melin P, Vilhardt H. Oxytocin receptor binding and uterotonic activity of carbetocin and its metabolites following enzymatic degradation. Eur J Pharmacol. 1998 Aug 21;355(2-3):203-10. doi: 10.1016/s0014-2999(98)00513-5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 18, 2020 | |
| Reset | Jun 3, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2020 | Jun 3, 2020 |
| 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 |
|---|---|
| D010121 | Oxytocin |
| C020731 | carbetocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Carbetocin |
| Drug |
To be given to Carbetocin group following the clamping of the umbilical cord |
|
| Intraoperative period |
| Need for additional uterotonics | Total dose (milligrams) of additional uterotonics administered | Starting from the preoperative period, ending at the 24th postoperative hour |
| Blood transfusion | Total volume (milliliters) of blood transfused | Starting from the clamping of the umbilical cord, ending at the 24th postoperative hour |
| 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 |