Carbetocin Compared To Oxytocin During Cesarean Delivery

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05758012

Collaborator

Ministry of Health, Kuwait (Other)

260

Enrollment

Location

19.1

Anticipated Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Delivery	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 Design

Study Type:

Observational

Anticipated Enrollment :

260 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Myocardial effects [immediately before drug administration]
Electrocardiograph (QT interval)
Myocardial effects [24 hours after drug administration]
Electrocardiograph (QT interval)

Secondary Outcome Measures

Cardiac enzyme [immediately before drug administration]
Troponin
Cardiac enzyme [24 hours after drug administration]
Troponin
Uterine contraction [One hour post delivery]
Palpate the fundus throughout a contraction to determine intensity

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Munistery of Health Kuwait	Kuwait		Kuwait

Sponsors and Collaborators

Assiut University
Ministry of Health, Kuwait

Investigators

Principal Investigator: Fatemah Qasem, Ministry of Health, Kuwait

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Abdelrady S Ibrahim, MD, Professor of Anesthesia and ICU, Assiut University

ClinicalTrials.gov Identifier:

NCT05758012

Other Study ID Numbers:

IRB0000871251

First Posted:

Mar 7, 2023

Last Update Posted:

Mar 7, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Oxytocin

Carbetocin

Study Results

No Results Posted as of Mar 7, 2023