Carbetocin Compared To Oxytocin During Cesarean Delivery

Not yet recruiting

• Conditions: Cesarean Delivery
• Interventions: Drug: Carbetocin; Drug: oxytocin

• Registration Number: NCT05758012
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-11-04
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-04
• Last Update Submitted: 2023-03-04
• Study First Posted: 2023-03-07
• Last Update Posted: 2023-03-07
• Study Start: 2023-05-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 260

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carbetocin group	Carbetocin	Carbetocin 100 μg will be administered by a trained anaesthetist as a one-minute IV injection.
oxytocin group	oxytocin	Oxytocin 5 IU will be administered by a trained anaesthetist as a one-minute IV injection.

Primary Outcome Measures

Name	Time	Method
Myocardial effects	24 hours after drug administration	Electrocardiograph (QT interval)

Secondary Outcome Measures

Name	Time	Method
Cardiac enzyme	24 hours after drug administration	Troponin
Uterine contraction	One hour post delivery	Palpate the fundus throughout a contraction to determine intensity

Trial Locations

Locations (1)

Munistery of Health Kuwait; 🇰🇼 Kuwait, Kuwait