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Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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 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.
Official title: Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery: a Double-blind Randomized Control Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-12-01
Completion Date
2026-12
Last Updated
2026-04-01
Healthy Volunteers
Yes
Conditions
Interventions
Calcium Chloride
Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.
Placebo
Intravenous administration of 100ml normal saline, over 10 minutes.
Carbetocin
50 mcg intravenous carbetocin.
Locations (1)
Mount Sinai Hospital
Toronto, Ontario, Canada