Cardiac IschemiaPhase 4NCT06946589
Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section
A Phase 4 study testing Carbetocin in people with Cardiac Ischemia and Cesarian Section, run by Jordan Leitch at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiac Ischemia, Cesarian Section
- What is being tested?
- Carbetocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective cesarian section
- Primary and repeat cesarian section
Who cannot join
- Prior and current cardiovascular co-morbidities including pre-eclampsia
- BMI greater than 50
- Pre-existing bleeding disorders
- Allergy to carbetocin
- Age under 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Taylor C. M. Perry, (613) 548-3232, taylorchristina.perry@kingstonHSC.ca
Jordan Leitch, jordan.leitch@kingstonHSC.ca
About this study
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.
Read more
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
- Being tested
- Carbetocin
- Keywords
- carbetocin, duratocin, cardiac symptoms
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported symptoms
Subjective patient reported symptoms of cardiac ischemia, reported with descriptive words
Measured: within 5 minutes of study drug administration
Secondary outcomes (2)
Troponin I levels
Troponin I levels on blood work
Measured: One day after study drug administration
ECG: ST segment
Changes to the ST segment on ECG
Measured: 5 minutes after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan Leitch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jordan Leitch, Queen's University
- Investigators
- Jordan Leitch, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946589
- Sponsor's protocol ID
- 69135
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section
- ClinicalTrials.gov ID
- NCT06946589
- Acronym / sponsor ID
- 69135
- Conditions
- Cardiac Ischemia, Cesarian Section
- Keywords
- carbetocin, duratocin, cardiac symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jordan LeitchUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50mcg of Carbetocin | Experimental | Drug: CarbetocinParticipants 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. |
| 100mcg of Carbetocin | Active comparator | Drug: CarbetocinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing elective cesarian section
- Primary and repeat cesarian section
Key exclusion criteria (5 listed)
- Prior and current cardiovascular co-morbidities including pre-eclampsia
- BMI greater than 50
- Pre-existing bleeding disorders
- Allergy to carbetocin
- Age under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbetocinA uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section | Drug | 100mcg of Carbetocin, 50mcg of Carbetocin |
Primary outcome
Patient reported symptoms
Time frame: within 5 minutes of study drug administration
Subjective patient reported symptoms of cardiac ischemia, reported with descriptive words
2 secondary outcomes
Troponin I levels
Time frame: One day after study drug administration
ECG: ST segment
Time frame: 5 minutes after study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordan Leitch, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carbetocin in people with Cardiac Ischemia and Cesarian Section, run by Jordan Leitch at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Leitch, MD (613-549-6666, jordan.leitch@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported symptoms (time frame: within 5 minutes of study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.