Carbetocin Compared To Oxytocin During Cesarean Delivery

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

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 Overview

• Status: Not yet recruiting
• Conditions: Cesarean Delivery
• Intervention / Treatment: Drug: oxytocin; Drug: Carbetocin

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 Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

• Study Contact: Name: Fatemah Qasem; Phone Number: +98599511550; Email: fatemahq82@gmail.com
• Study Contact Backup: Name: Mohamed Farghaly; Phone Number: +96551199166; Email: mohamedfarghali@hotmail.com

Study Locations

• Kuwait
  • Kuwait, Kuwait
    • Munistery of Health Kuwait
    • Contact: Mohamed Farghaly; Phone Number: +96551199166; Email: mohamedfarghali@hotmail.com
    • Contact: Fatemah Qasem; Phone Number: +96599511550; Email: fatemahq82@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women will be recruited from the pregnant women attending antenatal clinics in Sabah Maternity Hospital and planned for Delivery either vaginal or Cesarean section .

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
oxytocin group; Oxytocin 5 IU will be administered by a trained anaesthetist as a one-minute IV injection.	Drug: oxytocin; Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders; Other Names: Syntocinon
Carbetocin group; Carbetocin 100 μg will be administered by a trained anaesthetist as a one-minute IV injection.	Drug: Carbetocin; Participants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders; Other Names: Pabal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial effects	Electrocardiograph (QT interval)	immediately before drug administration
Myocardial effects	Electrocardiograph (QT interval)	24 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac enzyme	Troponin	immediately before drug administration
Cardiac enzyme	Troponin	24 hours after drug administration
Uterine contraction	Palpate the fundus throughout a contraction to determine intensity	One hour post delivery

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: Ministry of Health, Kuwait
• Investigators: Principal Investigator: Fatemah Qasem, Ministry of Health, Kuwait

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: March 4, 2023
• First Posted (Estimate): March 7, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 4, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin; Carbetocin
• Other Study ID Numbers: IRB0000871251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: the results of the study will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No