Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Carbetocin; Drug: Oxytocin

• Registration Number: NCT03939806
• Lead Sponsor: Ufuk University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-05
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carbetocin	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.
Oxytocin	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.

Primary Outcome Measures

Name	Time	Method
Urinary sodium	Preoperative, Postoperative 2nd, 4th, 24th hours	The change in urinary sodium content (milligrams) compared to the preoperative period
Urine volume	Intraoperative period	Total amount of intraoperative urine output in milliliters
Blood sodium	Preoperative, Postoperative 2nd, 4th, 24th hours	The change in blood sodium content (milligrams) compared to the preoperative period

Secondary Outcome Measures

Name	Time	Method
Blood transfusion	Starting from the clamping of the umbilical cord, ending at the 24th postoperative hour	Total volume (milliliters) of blood transfused
Blood loss	Intraoperative period	The total volume of intraoperative blood loss
Blood osmolality	Preoperative, Postoperative 2nd, 4th, 24th hours	The change in blood osmolality compared to the preoperative period
Need for additional uterotonics	Starting from the preoperative period, ending at the 24th postoperative hour	Total dose (milligrams) of additional uterotonics administered

Trial Locations

Locations (1)

Ufuk University Faculty of Medicine Hospital; 🇹🇷 Ankara, Balgat, Turkey