Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

NCT06946589 | Not Yet Recruiting Phase 4

• 1 other identifier: 69135
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

carbetocin; duratocin; cardiac symptoms

Outcome Measures

Primary Outcomes (1)

• Patient reported symptoms

  Subjective patient reported symptoms of cardiac ischemia, reported with descriptive words

  within 5 minutes of study drug administration

Secondary Outcomes (2)

• Troponin I levels

  One day after study drug administration

• ECG: ST segment

  5 minutes after study drug administration

Other Outcomes (3)

• Estimated blood loss during surgery

  Within 1 hour of study drug administration

• Surgeons assessment of uterine tone

  3 minutes after study drug administration

• Hemoglobin change

  Preoperatively and one day postoperatively

Study Arms (2)

50mcg of Carbetocin

EXPERIMENTAL

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.

Drug: Carbetocin

100mcg of Carbetocin

ACTIVE COMPARATOR

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.

Drug: Carbetocin

Interventions

Carbetocin DRUG

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

100mcg of Carbetocin; 50mcg of Carbetocin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective cesarian section
• Primary and repeat cesarian section

You may not qualify if:

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

Sponsors & Collaborators

• Jordan Leitch: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

carbetocin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jordan Leitch, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Leitch, MD

CONTACT

613-549-6666; jordan.leitch@kingstonhsc.ca

Taylor Perry, MD

CONTACT

(613) 548-3232; taylorchristina.perry@kingstonHSC.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Jordan Leitch, Assistant Professor, Dept. of Anesthesiology/Critical Care, Queen's University

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 27, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)