Carbetocin Compared To Oxytocin During Cesarean Delivery

Cesarean Delivery Clinical Trial

Official title:

Undesired Effects of Carbetocin Compared To Oxytocin Administered As Single Intravenous Dose or Infusion During Cesarean Delivery: A Prospective Randomised Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05758012
• Other study ID #: IRB0000871251
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Fatemah Qasem
• Phone: +98599511550
• Email: fatemahq82[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Delivery

Intervention

Drug:
• oxytocin
Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders
• Carbetocin
Participants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders

Locations

Country	Name	City	State
Kuwait	Munistery of Health Kuwait	Kuwait

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Ministry of Health, Kuwait

Country where clinical trial is conducted

Kuwait, 

References & Publications (1)

Masuzawa Y, Kataoka Y, Fujii K, Inoue S. Prophylactic management of postpartum haemorrhage in the third stage of labour: an overview of systematic reviews. Syst Rev. 2018 Oct 11;7(1):156. doi: 10.1186/s13643-018-0817-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial effects	Electrocardiograph (QT interval)	immediately before drug administration
Primary	Myocardial effects	Electrocardiograph (QT interval)	24 hours after drug administration
Secondary	Cardiac enzyme	Troponin	immediately before drug administration
Secondary	Cardiac enzyme	Troponin	24 hours after drug administration
Secondary	Uterine contraction	Palpate the fundus throughout a contraction to determine intensity	One hour post delivery