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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a lower dose of carbetocin, used to prevent excessive bleeding after childbirth, results in fewer heart-related side effects during a C-section compared to the usual dose. Participants will receive either 50mcg or 100mcg of carbetocin and will be monitored for heart symptoms and changes in heart-related tests. It suits individuals undergoing an elective C-section without heart conditions or bleeding disorders. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for carbetocin?

Research shows that carbetocin is generally safe for use during cesarean sections. Studies have found it to be heart-safe, especially compared to oxytocin, another common drug used to prevent heavy bleeding after childbirth. Patients using carbetocin have reported fewer side effects than those using oxytocin.

Carbetocin is already approved for preventing heavy bleeding after childbirth, indicating its safety in similar situations. This trial examines whether a lower dose of carbetocin (50mcg) might cause fewer heart-related side effects than the usual 100mcg dose. The focus is on symptoms reported by patients, changes in heart activity, and levels of a heart enzyme called troponin.

Overall, previous research suggests that carbetocin is safe, and this trial seeks to determine if a lower dose might further benefit heart health. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about carbetocin for managing post-partum hemorrhage (PPH) during C-sections because it offers a potentially superior alternative to traditional treatments like oxytocin. Unlike oxytocin, which requires continuous infusion, carbetocin can be administered as a single injection, making it more convenient for both patients and healthcare providers. Furthermore, carbetocin has a longer duration of action, which may provide more sustained protection against bleeding. This could lead to improved outcomes for new mothers by reducing the risk of excessive bleeding after delivery.

What evidence suggests that a reduced dose of carbetocin might be effective for cardiac symptoms during C-section?

Research has shown that carbetocin helps prevent heavy bleeding after childbirth, particularly during C-sections. Studies have found that carbetocin is more effective than oxytocin, another common drug for this purpose, significantly reducing the risk of heavy bleeding after birth. In Taiwan, using carbetocin during C-sections resulted in less blood loss compared to vaginal births. This trial will compare two dosages of carbetocin, 50mcg and 100mcg, to evaluate their effectiveness in managing bleeding during and after a C-section. Overall, carbetocin serves as a reliable option for managing bleeding during and after a C-section. ^{6 7 8 9 10}

Who Is on the Research Team?

Jordan Leitch, MD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK546425/

Carbetocin for the Prevention of Post-Partum Hemorrhage In a subgroup analysis and a smaller systematic review, carbetocin was more effective than oxytocin for PPH prevention for cesarean delivery, ...

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.18358

Carbetocin for Postpartum Haemorrhage Prophylaxis in All ... For both the vaginal birth and caesarean section analyses, compared to Oxytocin, Carbetocin significantly reduced the odds of PPH. TABLE 3.

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0279130

Cost-effectiveness analysis of carbetocin for prevention of ... In base-case analysis, carbetocin (versus oxytocin) reduced PPH-related cost (by USD29 per birth), PPH ≥500 mL and ≥1,500 mL (by 13.7 and 1.9 per 1,000 births), ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1028455916301917

Carbetocin in prevention of postpartum hemorrhage In Taiwan, prophylactic use of carbetocin resulted in significantly less blood loss and incidence of PPH in cesarean than in vaginal deliveries.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03959436

Database Evaluating Outcomes of Using Carbetocin as the ... Data regarding additional uterotonic use and impact of carbetocin use during CD on intra and postoperative outcomes are gathered and analyzed. The primary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3671813/

Carbetocin versus oxytocin in caesarean section with high ... This result suggests that carbetocin seems to have an acceptable haemodynamic safety profile. Currently, pre-eclampsia, eclampsia and general anaesthesia are ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211524003506

Carbetocin versus oxytocin for the prevention of ... Carbetocin reduced the prevalence of PPH during caesarean section in a patient at high risk of bleeding compared to oxytocin. Most studies have assessed a ...

8. mdpi.com mdpi.com/2077-0383/14/20/7211

Adverse Effects of Oxytocin Are More Prevalent than Those ... Carbetocin versus oxytocin in caesarean section with high risk of post-partum haemorrhage. J. Prenat. Med. 2013, 7, 12–18. [Google Scholar] [CrossRef] ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01725243

Carbetocin at Cesarean Delivery for Labor Arrest The results of this study will establish the minimum effective dose of carbetocin for uterine contraction at cesarean delivery for labor arrest. This will ...

10. cureus.com cureus.com/articles/130417-efficacy-and-safety-of-carbetocin-versus-misoprostol-in-cesarean-section-a-systematic-review-and-meta-analysis

Efficacy and Safety of Carbetocin Versus Misoprostol in ... In conclusion, from the efficacy and safety prospect, for women who underwent CS, carbetocin is more effective and safer in preventing and ...