Carbetocin Compared To Oxytocin During Cesarean Delivery

Assiut University

Status: Not yet enrolling

Conditions: Cesarean Delivery

Treatments: Drug: oxytocin; Drug: Carbetocin

Study type: Observational

Funder types: Other

Identifiers

NCT05758012

IRB0000871251

Details and patient eligibility

About

As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.

Full description

Although the difference between carbetocin and oxytocin in terms of hemodynamic changes, postpartum blood loss and incidence of side effects is not statistically significant. serious cardiovascular adverse events, including ST segment depression, hypotension and tachycardia have been reported after IV oxytocin. Oxytocin dose reduction and/or increased infusion duration may reduce risk of some cardiac-related adverse effects and increase patient safety. As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.

Enrollment: 260 estimated patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal singleton pregnancy at gestational age of 36 weeks or more.
• Women with common comorbid diagnoses (diabetes, hypothyroidism, hypertension)
• pregnancy after in vitro fertilization

Exclusion criteria

• placenta praevia or invasive placenta.
• pre-eclampsia.
• Bleeding disorder, such as von Willebrand disease type I.
• Current treatment with low-molecular-weight heparin or other anticoagulation medication (not including aspirin).
• Any known intolerance to either of the study drugs.
• Prolonged QT-time.
• Other serious cardiac disease.
• Liver or kidney failure.

Trial design

260 participants in 2 patient groups

oxytocin group

Description:

Oxytocin 5 IU will be administered by a trained anaesthetist as a one-minute IV injection.

Treatment:

Drug: oxytocin

Carbetocin group

Description:

Carbetocin 100 μg will be administered by a trained anaesthetist as a one-minute IV injection.

Treatment:

Drug: Carbetocin