Comparison Of The Effects Of Carbetocin And Oxytocin In C-Sectıon

Compariıson Of The Effects Of Carbetocin And Oxytocin, Which Are Uterotonic Agents, In C-Section Operations

Obstetric hemorrhage is the most common cause of maternal mortality worldwide and its incidence is estimated to be approximately 24%. A series of studies has shown that the risk of serious postpartum hemorrhage decreases with correct and active management in the third stage of labor. And the routine use of uterotonic agents underlies effective management. It has been reported that the routine use of uterotonic agents (oxytocin, carbetocin, ergometrine, etc.) reduces the risk of postpartum bleeding by 40% on average. However, the uterotonic agent and dose protocol are still unclear. Oxytocin is the most preferred agent for postpartum hemorrhage prophylaxis after vaginal and cesarean delivery in cases without risk factors, as it has a rapid onset of effect, does not increase blood pressure, and does not cause a retained placenta. In cases where oxytocin cannot be used, other agents of choice are ergot derivatives and misoprostol. The use of carbetocin, a long-acting oxytocin analogue, is now recommended in the guidelines for risky vaginal deliveries and postpartum hemorrhage prophylaxis after C-section. Carbetocin also reduces the need for additional uterotonics. Although carbetocin has been approved for use by the ministry of health, it still has limited clinical use in Turkey. It is vital for the medical community to have more experience with using carbetocin, an agent cited in medical guidelines and is also available in our country, and to share their experiences on academic platforms. This study intends to investigate oxytocin and carbetocin, which are uterotonic agents used during C-section, in terms of haemodynamic changes they cause, their effects on the uterine tone and on bleeding as well as their side effects (flushing, headache, back pain, hypertension and tachycardia, nausea-vomiting, etc.), to determine if there are any differences between them and share our insights with the reader.

Study Overview

• Status: Not yet recruiting
• Conditions: Carbetocin; Oxytocic Drugs Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Drug: Oxytocin; Procedure: C-sections operations; Drug: Carbetocin

Detailed Description

Obstetric hemorrhage is the most common cause of maternal mortality worldwide and its incidence is estimated to be approximately 24%. A series of studies has shown that the risk of serious postpartum hemorrhage decreases with correct and active management in the third stage of labor. And the routine use of uterotonic agents underlies effective management. It has been reported that the routine use of uterotonic agents (oxytocin, carbetocin, ergometrine, etc.) reduces the risk of postpartum bleeding by 40% on average. However, the uterotonic agent and dose protocol are still unclear. Oxytocin is the most preferred agent for postpartum hemorrhage prophylaxis after vaginal and cesarean delivery in cases without risk factors, as it has a rapid onset of effect, does not increase blood pressure, and does not cause a retained placenta. In cases where oxytocin cannot be used, other agents of choice are ergot derivatives and misoprostol. The use of carbetocin, a long-acting oxytocin analogue, is now recommended in the guidelines for risky vaginal deliveries and postpartum hemorrhage prophylaxis after C-section. Carbetocin also reduces the need for additional uterotonics. Although carbetocin has been approved for use by the ministry of health, it still has limited clinical use in Turkey. It is vital for the medical community to have more experience with using carbetocin, an agent cited in medical guidelines and is also available in our country, and to share their experiences on academic platforms. This study intends to investigate oxytocin and carbetocin, which are uterotonic agents used during C-section, in terms of haemodynamic changes they cause, their effects on the uterine tone and on bleeding as well as their side effects (flushing, headache, back pain, hypertension and tachycardia, nausea-vomiting, etc.), to determine if there are any differences between them and share our insights with the reader.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: asuman sargın; Phone Number: +905327498824; Email: asuozdemir@hotmail.com
• Study Contact Backup: Name: ilkben günüşen; Email: ilkbengunusen@gmail.com

Study Locations

• Turkey
  • İ̇zmi̇r
    • Bornova, İ̇zmi̇r, Turkey, 35080
      • EÜTF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 18-45 years old
• Pregnant women to have a C-section,
• Subjects with no history of oxytocin allergy, At term, no multiple pregnancies, elective C-section

Exclusion Criteria:

Subjects refusing to take part,

• Subjects with a history of oxytocin allergy, Subjects scheduled for an emergency C-section, Multiple pregnancies, Having been diagnosed with diabetes mellitus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxytocin; (subjects administered oxytocin as a uterotonic agent) (5 IU oxytocin diluted with 10 ml saline followed by slow injection) (for 3 minutes)	Drug: Oxytocin; Oxytocin; Procedure: C-sections operations; Immediately after the delivery of the baby, uterotonic agents will be applied before the placenta is removed and by a manual check of the fundus of the uterus and the anterior wall, followed by an examination of the uterine tone by the surgeon
Active Comparator: Carbetocin; subjects administered carbetocin as a uterotonic agent) (100µg carbetocin diluted with 10 ml saline followed by slow injection (for 3 minutes))	Procedure: C-sections operations; Immediately after the delivery of the baby, uterotonic agents will be applied before the placenta is removed and by a manual check of the fundus of the uterus and the anterior wall, followed by an examination of the uterine tone by the surgeon; Drug: Carbetocin; Carbetocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of uterotonic agents on uterine tone	uterine tone (standardized as Very good, Good, Sufficient, Atony),	intraoperative
hemorrhage	haemoglobin concentration	haemoglobin levels before and after 6 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in terms of haemodynamic changes uterotonic agents cause	Blood pressure (in mmHg),hypotansion	intraoperative time, after 30 minute
side effects of uterotonic agents	lushing, headache, back pain, hypertension and tachycardia, nausea-vomiting	postoperative,24 hours after caesarean section

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 9, 2023
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): June 21, 2023

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Oxytocin; C-section; Postpartum hemorrhage; Carbetocin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin; Carbetocin
• Other Study ID Numbers: ASargın

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