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RECRUITING
NCT07187544
NA

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Calcium Chloride

Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.

OTHER

Placebo

Intravenous administration of 100ml normal saline, over 10 minutes.

DRUG

Carbetocin

50 mcg intravenous carbetocin.

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada