Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery: a Double-blind Randomized Control Trial
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
120 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria13
- 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.
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Interventions
Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.
Intravenous administration of 100ml normal saline, over 10 minutes.
50 mcg intravenous carbetocin.
Locations(1)
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NCT07187544