Carbetocin for Postpartum Hemorrhage
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?
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Ex-Vivo Testing
Dose-response testing with varying concentrations of calcium chloride and carbetocin, with and without oxytocin pre-exposure
Follow-up
Participants are monitored for safety and effectiveness after ex-vivo testing
What Are the Treatments Tested in This Trial?
Interventions
- Carbetocin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead Sponsor