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

NCT05742854 | Unknown Phase 4 DMC

• 1 other identifier: ASargın
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carbetocin; Oxytocic Drugs Causing Adverse Effects in Therapeutic Use

Keywords

Carbetocin; C-section; Postpartum hemorrhage; Oxytocin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• in terms of haemodynamic changes uterotonic agents cause

  intraoperative time, after 30 minute

• side effects of uterotonic agents

  postoperative,24 hours after caesarean section

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

(subjects administered oxytocin as a uterotonic agent) (5 IU oxytocin diluted with 10 ml saline followed by slow injection) (for 3 minutes)

Procedure: C-sections operations; Drug: Oxytocin

Carbetocin

ACTIVE COMPARATOR

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; Drug: Carbetocin

Interventions

C-sections operations PROCEDURE

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

Carbetocin; Oxytocin

Oxytocin DRUG

Oxytocin

Oxytocin

Carbetocin DRUG

Carbetocin

Carbetocin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

EÜTF

Bornova, İ̇zmi̇r, 35080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

asuman sargın

CONTACT

+905327498824; asuozdemir@hotmail.com

ilkben günüşen

CONTACT

ilkbengunusen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 24, 2023
• Study Start: March 9, 2023
• Primary Completion: May 31, 2023
• Study Completion: June 21, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)