Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections

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

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.

Study Overview

• Status: Unknown
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Oxytocin; Drug: Carbetocin

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Gamze S Çağlar, Prof.Dr.; Phone Number: +903122044000; Email: gamzesinem@hotmail.com
• Study Contact Backup: Name: Baturay K Kazbek, MD; Phone Number: +903122044000; Email: bkkazbek@gmail.com

Study Locations

• Turkey
  • Balgat
    • Ankara, Balgat, Turkey, 06510
      • Ufuk University Faculty of Medicine Hospital
      • Contact: Baturay K Kazbek, MD; Phone Number: +903122044000; Email: bkkazbek@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study population consists of term (gestational age greater than 37 weeks) pregnant women scheduled to undergo elective cesarean section.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Oxytocin; To be given to Oxytocin group following the clamping of the umbilical cord
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.	Drug: Carbetocin; To be given to Carbetocin group following the clamping of the umbilical cord

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ufuk University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin; Carbetocin
• Other Study ID Numbers: CO2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No