Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections

Study Overview
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Brief Summary
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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.

Official Title
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Renal Effects of Carbetocin and Oxytocin in Cesarean Section for Preventing Post-partum Haemorrhage: a Prospective Randomized Study

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Carbetocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term (>37 weeks of gestation) uncomplicated pregnant women undergoing elective cesarean section Exclusion Criteria: Patients refusing to participate in the study Complicated pregnancies Patients with risk factors for postpartum hemorrhage Contraindications for oxytocin or carbetocin usage Patients with known renal diseases Preterm births (<37 weeks of gestation)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oxytocin<br>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. | Drug: Oxytocin<br>* To be given to Oxytocin group following the clamping of the umbilical cord<br>|
| Carbetocin<br>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. | Drug: Carbetocin<br>* To be given to Carbetocin group following the clamping of the umbilical cord<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |