Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Underg… (NCT07187544) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Canada120 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Uterine Tone 10 minutes
Timeframe: 10 minutes
Trial details
NCT IDNCT07187544
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital
✕. 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)