Status:
RECRUITING
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions:
Postpartum Hemorrhage (Primary)
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Postpartum hemorrhage (PPH) is a leading cause of maternal mortality, and its severity has been increasing globally, including in high-income countries. The most common cause of PPH is uterine atony o...
Eligibility Criteria
Inclusion
- Scheduled CD for patients ≥ 37 weeks excluding high risk factors for uterine atony
- Neuraxial anesthesia as the primary anesthetic where intrathecal medications are the primary anesthetic
Exclusion
- Risk factors for uterine atony including:
- Overdistended uterus due to fetal macrosomia reported on prenatal ultrasound \>90th centile or \> 4000 gm, multiple gestation, grand multiparity (≥5 births at ≥ 20 weeks gestation), polyhydramnios
- History of uterine atony/PPH (documented with blood loss \> 2000 ml, blood transfusion, use of surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)
- Obesity with body mass index (BMI) \> 40 kg/m2
- Placenta previa and/or placenta accreta
- Digoxin therapy within 14 days (hypercalcemia can exacerbate digoxin toxicity)
- Patients needing intraoperative IV ceftriaxone or tetracycline.
- Kidney disease including Stage 3 chronic kidney disease, serum creatinine above 120 mmol/L or GFR \<60 ml/min (to prevent hypercalcemia due to reduced creatinine clearance in those with impaired kidney function as calcium is renally excreted)
- Calcium channel blockade within 24 hours (opposing effect)
- Known history of cardiac disease including arrhythmias, ischemia, and congenital heart disease (to avoid attributing cardiac symptoms to study drugs)
- Preexisting hypertension, preeclampsia or persistent elevated blood pressure above 160/100 mmHg requiring treatment
- Emergency cesarean deliveries or women in labor
- Planned general anesthetic for patients where neuraxial is contraindicated.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07187544
Start Date
September 1 2025
End Date
September 1 2026
Last Update
September 23 2025
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5