Carbetocin Compared To Oxytocin During Cesarean Delivery | NCT05758012

Studies
Carbetocin Compared To Oxytocin During Cesarean Delivery

NCT05758012

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 7, 2023Actual

Enrollment

260Estimated

Phase

Not provided

Conditions

Cesarean Delivery

Interventions

oxytocin
Carbetocin

Countries

Kuwait

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Estimated

Primary Completion Date

Nov 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Nov 4, 2022

First Submission Date that Met QC Criteria

Mar 4, 2023

First Posted Date

Mar 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2023

Last Update Posted Date

Mar 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelrady S Ibrahim, MD, Professor of Anesthesia and ICU, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Name	Class
Ministry of Health, Kuwait	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxytocin	Drug	Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders	oxytocin group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Cardiac enzyme	Troponin	immediately before drug administration
Cardiac enzyme	Troponin	24 hours after drug administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

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 .

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fatemah Qasem	Contact	+98599511550		fatemahq82@gmail.com
Mohamed Farghaly	Contact	+96551199166		mohamedfarghali@hotmail.com

Overall Officials

Name	Affiliation	Role
Fatemah Qasem	Ministry of Health, Kuwait	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Munistery of Health Kuwait		Kuwait City			Kuwait

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30305154	Background	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.

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones