Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

NCT ID: NCT06946589

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-09-01

Brief Summary

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The goal of this project is to examine the cardiac symptoms and physiologic changes after administration of a reduced dose of carbetocin in participants undergoing elective cesarian section.

* Does reduced dose carbetocin (50mcg) have fewer cardiac side effects than usual dose carbetocin (100mcg) when comparing patient reported symptoms, ECG changes and troponin increases?
* Is there a relationship between patient reported cardiac symptoms after carbetocin administration and subjective measures of cardiac ischemia (ECG changes and troponin increases? Researchers will compare 50mcg of carbetocin to the control group of 100mcg of carbetocin in patients undergoing elective cesarian section.

Participants will:

* Be given 50mcg or 100mcg of carbetocin during cesarian section
* Asked to report cardiac symptoms
* Be assessed for ECG changes and blood loss using standard of practice monitoring
* Have a troponin I blood test completed after delivery

Detailed Description

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Conditions

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Cardiac Ischemia Cesarian Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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50mcg of Carbetocin

Participants in this arm will receive 50mcg of carbetocin for post party hemorrhage prophylaxis at the the time of umbilical cord clamping during their cesarian section.

Group Type EXPERIMENTAL

Carbetocin

Intervention Type DRUG

A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section

100mcg of Carbetocin

Participants in this arm will receive 100mcg of carbetocin for post party hemorrhage prophylaxis at the the time of umbilical cord clamping during their cesarian section.

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section

Interventions

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Carbetocin

A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Undergoing elective cesarian section
* Primary and repeat cesarian section

Exclusion Criteria

* Prior and current cardiovascular co-morbidities including pre-eclampsia
* BMI greater than 50
* Pre-existing bleeding disorders
* Allergy to carbetocin
* Age under 18
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jordan Leitch

OTHER

Sponsor Role lead

Responsible Party

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Jordan Leitch

Dr. Jordan Leitch, Assistant Professor, Dept. of Anesthesiology/Critical Care, Queen's University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jordan Leitch, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Jordan Leitch, MD

Role: CONTACT

613-549-6666

Taylor Perry, MD

Role: CONTACT

(613) 548-3232

Facility Contacts

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Taylor C. M. Perry

Role: primary

(613) 548-3232

Jordan Leitch

Role: backup

Other Identifiers

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69135

Identifier Type: -

Identifier Source: org_study_id

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