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NCT Number: NCT06946589

Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

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

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Key information

Conditions

Cardiac Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Cesarian Section Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbetocin

Drug

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

Primary outcomes

  1. Patient reported symptoms

    Time frame: within 5 minutes of study drug administration

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

Secondary outcomes

  1. Troponin I levels

    Time frame: One day after study drug administration

    Troponin I levels on blood work

  2. ECG: ST segment

    Time frame: 5 minutes after study drug administration

    Changes to the ST segment on ECG

Other outcomes

  1. Estimated blood loss during surgery

    Time frame: Within 1 hour of study drug administration

    Recorded from anesthesiologists assessment

  2. Surgeons assessment of uterine tone

    Time frame: 3 minutes after study drug administration

    Assessed as a binary of adequate or not adequate

  3. Hemoglobin change

    Time frame: Preoperatively and one day postoperatively

    Assessed as a difference between preoperative and postoperative hemoglobin

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Leitch, MD

CONTACT

[email protected]

613-549-6666

Taylor Perry, MD

CONTACT

[email protected]

(613) 548-3232

Sponsors and collaborators

Lead sponsor

Jordan Leitch

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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