Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03939806
• Other study ID #: CO2019
• Status: Not yet recruiting
• Start date: May 2019
• Est. completion date: June 2019

Study information

• Verified date: May 2019
• Source: Ufuk University
• Contact: Gamze S Çaglar, Prof.Dr.
• Phone: +903122044000
• Email: gamzesinem[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
To be given to Oxytocin group following the clamping of the umbilical cord
• Carbetocin
To be given to Carbetocin group following the clamping of the umbilical cord

Locations

Country	Name	City	State
Turkey	Ufuk University Faculty of Medicine Hospital	Ankara	Balgat

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Engstrøm 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine volume	Total amount of intraoperative urine output in milliliters	Intraoperative period
Primary	Urinary sodium	The change in urinary sodium content (milligrams) compared to the preoperative period	Preoperative, Postoperative 2nd, 4th, 24th hours
Primary	Blood sodium	The change in blood sodium content (milligrams) compared to the preoperative period	Preoperative, Postoperative 2nd, 4th, 24th hours
Secondary	Blood osmolality	The change in blood osmolality compared to the preoperative period	Preoperative, Postoperative 2nd, 4th, 24th hours
Secondary	Blood loss	The total volume of intraoperative blood loss	Intraoperative period
Secondary	Need for additional uterotonics	Total dose (milligrams) of additional uterotonics administered	Starting from the preoperative period, ending at the 24th postoperative hour
Secondary	Blood transfusion	Total volume (milliliters) of blood transfused	Starting from the clamping of the umbilical cord, ending at the 24th postoperative hour