Investigating how calcium affects carbetocin's ability to contract the uterus after cesarean delivery
Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium: An Ex-Vivo Study
This study is testing if different levels of calcium can help carbetocin work better to make the uterus contract after a cesarean delivery to prevent heavy bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06930391 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the role of extracellular calcium in enhancing the contractility of the human myometrium when treated with carbetocin, a uterotonic agent used to prevent postpartum hemorrhage (PPH) during cesarean deliveries. By examining non-laboring women scheduled for cesarean sections, the research will assess how varying calcium levels influence uterine contractions in response to carbetocin. The findings could provide insights into optimizing PPH management, especially for women with comorbidities that increase their risk of bleeding. This is the first ex vivo study to investigate this relationship, potentially paving the way for improved treatment protocols.
Who should consider this trial
Good fit: Ideal candidates are non-laboring women between 37 to 41 weeks of gestation scheduled for a primary or first repeat cesarean delivery.
Not a fit: Patients who may not benefit include those requiring general anesthesia, with a history of uterine atony, or those with conditions predisposing them to postpartum hemorrhage.
Why it matters
Potential benefit: If successful, this study could lead to enhanced management of postpartum hemorrhage, reducing risks for women undergoing cesarean deliveries.
How similar studies have performed: While this specific approach is novel, previous studies have shown the importance of calcium in uterine contractility, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * non-laboring women with gestational age between 37 to 41 weeks * not exposed to exogenous oxytocin, scheduled for a primary or first repeat cesarean delivery under neuraxial anesthesia. Exclusion criteria: * patients requiring general anesthesia * more than 1 previous cesarean delivery * history of uterine atony * emergency cesarean section in labor * patients using medications that could affect myometrial contractility such as nifedipine, labetalol, or magnesium sulphate. * patients with any condition of predisposing to uterine atony and postpartum hemorrhage, such as abnormal placentation, multiple gestation, severe preeclampsia, macrosomia, polyhydroamnios, large uterine fibroids, chorioamnionitis, previous history of postpartum bleeding.
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Mrinalini Balki, MD
- Email: mrinalini.balki@uhn.ca
- Phone: 416-586-480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.