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

Ege University

Status and phase: Not yet enrolling; Phase 4

Conditions: Oxytocic Drugs Causing Adverse Effects in Therapeutic Use; Carbetocin

Treatments: Drug: Oxytocin; Drug: Carbetocin; Procedure: C-sections operations

Study type: Interventional

Funder types: Other

Identifiers

NCT05742854

ASargın

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Oxytocin

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin

Procedure: C-sections operations

Carbetocin

Active Comparator group

Description:

subjects administered carbetocin as a uterotonic agent) (100µg carbetocin diluted with 10 ml saline followed by slow injection (for 3 minutes))

Treatment:

Drug: Carbetocin

Procedure: C-sections operations