Carbetocin for C-section

Overseen By Taylor Perry, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Jordan Leitch

Disqualifiers: Cardiovascular issues, BMI > 50, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Carbetocin for C-section?

Research shows that Carbetocin, a long-acting version of oxytocin, is effective in reducing the need for additional medications to control bleeding during and after a C-section. It has been compared to oxytocin and found to be effective in preventing postpartum hemorrhage (heavy bleeding after childbirth) in women undergoing both elective and non-elective C-sections. ^{1 2 3 4 5}

How is the drug Carbetocin different from other treatments for C-section?

Carbetocin is unique because it is a long-acting oxytocin receptor agonist (a substance that activates the same receptors as oxytocin) and is used to reduce the need for additional uterotonics (drugs that help the uterus contract) during non-elective C-sections. Unlike oxytocin, Carbetocin is administered as a single intravenous bolus (a quick injection into the vein), which may offer more convenience and potentially better control of uterine bleeding. ^{1 2 3 6 7}

What is the purpose of this trial?

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

Research Team

Jordan Leitch, MD

Principal Investigator

Queen's University

Eligibility Criteria

This trial is for individuals over 18 years old undergoing an elective cesarean section, whether it's their first or a repeat procedure. It excludes those with cardiovascular issues like pre-eclampsia, a BMI over 50, bleeding disorders, or allergies to carbetocin.

Inclusion Criteria

Undergoing elective cesarian section

I have had a C-section before and may need another.

Exclusion Criteria

Allergy to carbetocin

I have a bleeding disorder.

I have heart-related health issues, including a history of pre-eclampsia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 50mcg or 100mcg of carbetocin during cesarian section and are monitored for cardiac symptoms and physiological changes

1 day

1 visit (in-person)

Immediate Post-Treatment Monitoring

Participants are assessed for ECG changes, blood loss, and uterine tone immediately after drug administration

1 hour

Follow-up

Participants are monitored for troponin I levels and hemoglobin changes one day after treatment

1 day

Treatment Details

Interventions

• Carbetocin

Trial Overview The study tests if a reduced dose of carbetocin (50mcg) leads to fewer cardiac side effects compared to the usual dose (100mcg). Participants will receive one of the two doses during surgery and will be monitored for heart symptoms, ECG changes, blood loss, and troponin levels post-delivery.

Participant Groups

Group I: 50mcg of Carbetocin Experimental Treatment 1 Intervention

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 II: 100mcg of Carbetocin Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Jordan Leitch

Lead Sponsor

Trials

1

Recruited

50+

Jordan Leitch

Lead Sponsor

Trials

2

Recruited

520+

References

1. England pubmed.ncbi.nlm.nih.gov

Carbetocin versus oxytocin to reduce additional uterotonic use at non-elective caesarean section: a double-blind, randomised trial (.). [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Carbetocin compared with oxytocin in non-elective Cesarean delivery: a systematic review, meta-analysis, and trial sequential analysis of randomized-controlled trials. [2021]

3. France pubmed.ncbi.nlm.nih.gov

[Use of carbetocin in prevention of uterine atony during cesarean section. Comparison with oxytocin]. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Carbetocin versus syntometrine for prevention of postpartum hemorrhage after cesarean section. [2023]

5. Poland pubmed.ncbi.nlm.nih.gov

[Evaluation of carbetocin (pabal) efficacy in the prevention of the postpartum hemorrhage in women after cesarean section--preliminary report]. [2017]

6. Mexico pubmed.ncbi.nlm.nih.gov

[Biochemical markers of cardiac damage increased after carbetocin infusion during cesarean section]. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Carbetocin Controls Intraoperative Blood Loss and Thickness of Myometrium in Scar Uterus Cases. [2023]