To Compare the Effects of Oxytocin and Carbetocin on Intraoperative Hemodynamic Changes in Cesarean Section Surgeries.

April 24, 2025 updated by: Nurettin KURT, Yuzuncu Yıl University

Van Yuzuncu Yil University Faculty of Medicine Ethics Committee

To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective caesarean section surgeries , aged 18-40 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each.

All cases will receive routine preparation for general anesthesia. All patients placed on the operating room will receive two large-bore vascular access. For anesthesia induction 2 mg/kg propofol and 0.5 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 2 MAC sevoflurane.Demographic data of the patients (age, height, weight), ASA score and surgical time will be recorded. During the operation, hemodynamic parameters will be recorded just before the drugs are given and at the 1st, 5th, 10th, 15th, 20th, 25th and 30th minutes after the drug is given. In addition, intraoperative blood loss and the need for additional uterotonics throughout the surgery will be recorded. All data will be recorded and statistical analysis will be made.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Tuşba
      • VAN, Tuşba, Turkey, 65100
        • Recruiting
        • Van Yuzuncu Yil University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients scheduled for caesarean sections
  • Between 18-40 years
  • ASA I-II group
  • Those who will undergo general anesthesia
  • Those between 35-40 weeks of pregnancy
  • 1st and 2nd caesarean sections

Exclusion Criteria:

  • Those who prefer spinal or epidural anesthesia
  • Those who are outside the age range of 18-40
  • Those who are ASA III and above
  • Those with HT, DM, cardiac and respiratory diseases
  • Preeclampsia, eclampsia, HELLP
  • Those with a history of drug use that affects the cardiovascular system
  • Placenta Previa, Placenta Acreta, Placenta Acreta

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin (Group-O)
Group-O: Oxytocin group (n:40). In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.
Procedure: Group-O
In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.
Other Names:
  • Group Oxytocine
Experimental: Carbetocin (Group-C)
Group-C: Carbetocin group (n:40). In cesarean surgery, 100 μg carbetocin IV bolus will be administered after the baby delivered.
Procedure: Group-C
100 iu carbetosin administered to carbetocin group
Other Names:
  • Group Carbetosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine tonus
Time Frame: For 30 minutes after carbetocin administration.
The effect of carbetocin on uterine tone will be evaluated by the surgical team using a numerical scoring scale between 0-10. A score of 0 will indicate atony, and a score of 10 will indicate full contraction.
For 30 minutes after carbetocin administration.
Additional uterotonic drug requirement
Time Frame: For 30 minutes after carbetocin administration.
If the uterine tone is 7 or below, the surgical team will perform uterine massage, and in patients who do not see a sufficient increase in uterine tone, an additional uterotonic, 0.2 mg methylergonavine (Methyl ampoule 0.2 mg/ml) will be administered IM by the anesthesia team and recorded.
For 30 minutes after carbetocin administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative bleeding
Time Frame: from drug administration to the end of surgery.
Total intraoperative bleeding was recorded by calculating and estimating the aspirator volume, pad-sponge-compress count and surgical area.
from drug administration to the end of surgery.
Mean Blood Pressure
Time Frame: Intraoperatively every 5 minutes
Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.
Intraoperatively every 5 minutes
Heart Rate
Time Frame: Intraoperatively every 5 minutes
Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method.
Intraoperatively every 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Investigators

  • Study Director: Şükran ŞS Sevimli, Assoc.Prof, Van Yüzüncü Yıl University Van/Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022/09-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol anda statistical analysis plan will be share with other researchers

IPD Sharing Time Frame

10 months

IPD Sharing Access Criteria

The access can be provided via the e-mail addresses below dr.nurettinkurt@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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