Actively Recruiting
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2026-04-01
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 occurring in about 70% of cases. Uterotonic agents, like oxytocin, are key in managing the third stage of labour to prevent PPH. Oxytocin is a short-acting medication and requires frequent dosing, however, carbetocin, a longer-acting analogue that can be administered as a single dose, provides sustained uterotonic activity. Calcium chloride is a readily available, inexpensive medication that has been studied as an adjunct to primary uterotonics due to its role in uterine contractility. A randomized trial found no overall reduction in blood loss with calcium chloride and oxytocin, but a subgroup analysis suggested it may reduce bleeding in cases of uterine atony. This study was conducted in the US where carbetocin is not readily available. The investigators propose a double-blind randomized trial investigating if co-administering calcium chloride with carbetocin during scheduled cesarean deliveries reduces PPH secondary to uterine atony.
CONDITIONS
Official Title
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled cesarean delivery for patients at 37 weeks or more without high risk factors for uterine atony
- Use of neuraxial anesthesia with intrathecal medications as the primary anesthetic
You will not qualify if you...
- Risk factors for uterine atony such as overdistended uterus from large baby (>90th percentile or >4000 g), multiple gestation, grand multiparity (5 or more births at 20 weeks or more), or excess amniotic fluid
- History of uterine atony or postpartum hemorrhage requiring blood transfusion or surgical interventions
- Obesity with body mass index over 40 kg/m2
- Placenta previa or placenta accreta
- Digoxin therapy within 14 days
- Need for intraoperative intravenous ceftriaxone or tetracycline
- Kidney disease including stage 3 chronic kidney disease, serum creatinine above 120 mmol/L, or glomerular filtration rate below 60 ml/min
- Use of calcium channel blockers within 24 hours
- Known cardiac diseases including arrhythmias, ischemia, or congenital heart disease
- Preexisting hypertension, preeclampsia, or persistent high blood pressure above 160/100 mmHg requiring treatment
- Emergency cesarean deliveries or women in labor
- Planned general anesthesia where neuraxial anesthesia is contraindicated
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
M
Mrinalini Balki, MD
CONTACT
K
Kristi Downey, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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