40 Participants Needed

Carbetocin for Postpartum Hemorrhage

MB
Overseen ByMrinalini Balki, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Postpartum hemorrhage (PPH) continues to be an increasing problem globally. Uterotonics play an essential role in the pharmacological management of uterine atony. Carbetocin, a long acting analog of oxytocin has been recommended as a first line uterotonic for PPH prophylaxis at cesarean delivery. Considering many woman have associated comorbidities and are at high risk of PPH, finding alternative pharmacological agents is essential. Calcium is a key factor for myometrial contractions and calcium blood levels can be low at the end of pregnancy. Both hypocalcemia and hypercalcemia could lead to a decrease in myometrial contractions. It is already been demonstrated that in both desensitized and naïve myometrium, normocalcemia provides a better uterine tone compared to hypo and hypercalcemia when oxytocin is given as the first uterotonic drug.Currently, the role of extracelullar calcium in carbetocin- induced contractility is unknown. This will be the first ex vivo study to test the effects of extracellular calcium on oxytocin pretreated and naive myometrium. The results of this study will provide evidence on the use of this safe drug in clinical practice, particularly in women with labour arrest, and provide alternative pharmacological strategies to both prevention and treatment of PPH, thus improving our clinical practice.The investigators hypothesize that extracellular normocalcemia would provide superior carbetocin-mediated contractility in both naive and oxytocin-pretreated myometrium compared with hypercalcemia and hypocalcemia.

Will I have to stop taking my current medications?

If you are taking medications like nifedipine, labetalol, or magnesium sulphate, you may need to stop them, as they can affect myometrial contractility (the ability of the uterus to contract).

Is carbetocin safe for humans?

Carbetocin has a similar safety profile to oxytocin, which is commonly used to prevent postpartum hemorrhage, but more research is needed to confirm its safety.12345

How does the drug carbetocin differ from other treatments for postpartum hemorrhage?

Carbetocin is unique because it is a long-acting drug that helps the uterus contract to prevent postpartum hemorrhage, and it is often compared to oxytocin, which is shorter-acting. It is particularly noted for its effectiveness in high-risk women and those with hypertension (high blood pressure) undergoing cesarean sections.12456

What data supports the effectiveness of the drug Carbetocin for postpartum hemorrhage?

Research shows that Carbetocin is effective in preventing postpartum hemorrhage (severe bleeding after childbirth) when compared to other treatments like oxytocin, especially in women undergoing both vaginal and cesarean deliveries.12457

Are You a Good Fit for This Trial?

This trial is for women at high risk of postpartum hemorrhage (PPH), a condition where there's excessive bleeding after childbirth. It aims to find better treatments for those with uterine atony, which is when the uterus doesn't contract well.

Inclusion Criteria

I am pregnant, not in labor, and between 37 to 41 weeks along.
I have not been given oxytocin and am scheduled for my first or second C-section with spinal or epidural anesthesia.

Exclusion Criteria

More than 1 previous cesarean delivery
I have had uterine atony in the past.
I need general anesthesia for my treatment.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Ex-Vivo Testing

Dose-response testing with varying concentrations of calcium chloride and carbetocin, with and without oxytocin pre-exposure

4 hours

Follow-up

Participants are monitored for safety and effectiveness after ex-vivo testing

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Carbetocin
Trial Overview The study tests how different levels of calcium in the blood affect the ability of Carbetocin, a drug similar to Oxytocin, to make the uterus contract. The focus is on whether normal calcium levels improve these contractions more than low or high levels.
How Is the Trial Designed?
6Treatment groups
Active Control
Group I: Calcium 1.25nM with NO oxytocin pre-exposureActive Control2 Interventions
Group II: Calcium 2.5nM with NO oxytocin pre-exposureActive Control2 Interventions
Group III: Calcium 5.0nM with NO oxytocin pre-exposureActive Control2 Interventions
Group IV: Calcium 1.25nM with oxytocin pre-exposureActive Control3 Interventions
Group V: Calcium 2.5nM with oxytocin pre-exposureActive Control3 Interventions
Group VI: Calcium 5.0nM with oxytocin pre-exposureActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials
132
Recruited
11,400+

Published Research Related to This Trial

In a study of 160 hypertensive pregnant women undergoing cesarean section, carbetocin was found to significantly reduce postoperative blood loss compared to oxytocin, with blood loss averaging 424.75 ml in the carbetocin group versus 679.5 ml in the oxytocin group.
Carbetocin also maintained hemoglobin levels post-delivery, while oxytocin led to a significant decrease in hemoglobin, indicating that carbetocin may be a safer option for preventing postpartum hemorrhage in this patient population.
Carbetocin versus oxytocin for prevention of postpartum hemorrhage in hypertensive women undergoing elective cesarean section.Ibrahim, ZM., Sayed Ahmed, WA., Abd El-Hamid, EM., et al.[2021]
Carbetocin significantly reduces the need for additional uterotonic agents compared to oxytocin in women after cesarean delivery, indicating its efficacy in preventing postpartum hemorrhage.
Carbetocin has a lower risk of adverse effects compared to syntometrine during vaginal delivery, making it a potentially safer alternative for preventing postpartum hemorrhage, with similar effectiveness to other uterotonics.
Carbetocin for the prevention of postpartum hemorrhage: a systematic review and meta-analysis of randomized controlled trials.Jin, B., Du, Y., Zhang, F., et al.[2022]
A meta-analysis of 5 randomized controlled trials involving 30,314 women found that carbetocin is as effective as oxytocin in preventing postpartum hemorrhage during vaginal delivery, with no significant difference in blood loss of 500 ml or more.
Both carbetocin and oxytocin showed similar safety profiles, with no notable differences in side effects or the need for additional interventions, suggesting that the choice between them may depend on cost-effectiveness rather than efficacy or safety.
Carbetocin vs oxytocin for prevention of postpartum hemorrhage after vaginal delivery: A meta-analysis.Jin, XH., Li, D., Li, X.[2022]

Citations

Efficacy of carbetocin in the prevention of postpartum hemorrhage: a systematic review and Bayesian meta-analysis of randomized trials. [2022]
Carbetocin versus oxytocin for prevention of postpartum hemorrhage in hypertensive women undergoing elective cesarean section. [2021]
3.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
Carbetocin in prevention of postpartum hemorrhage: Experience in a tertiary medical center of Taiwan. [2017]
Carbetocin for the prevention of postpartum hemorrhage: a systematic review and meta-analysis of randomized controlled trials. [2022]
Carbetocin vs oxytocin for prevention of postpartum hemorrhage after vaginal delivery: A meta-analysis. [2022]
Carbetocin for the prevention of postpartum hemorrhage: a systematic review. [2018]
Carbetocin versus oxytocin for prevention of postpartum hemorrhage after vaginal delivery in high risk women. [2023]
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