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Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

NCT06946589 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-27

No results posted yet for this study

Summary

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

Conditions

  • Cardiac Ischemia
  • Cesarian Section

Interventions

DRUG

Carbetocin

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

Sponsors & Collaborators

  • Jordan Leitch

    lead OTHER

Principal Investigators

  • Jordan Leitch, MD · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-08-01
Completion
2027-09-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06946589 on ClinicalTrials.gov