Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery

NCT07187544 | Recruiting

• 2 other identifiers: 25-02300140
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage (Primary)

Keywords

calcium; carbetocin; cesarean

Outcome Measures

Primary Outcomes (1)

• Uterine Tone 10 minutes

  The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 10 minutes post-fetal delivery, utilizing a verbal numeric rating scale of 0-10.

  10 minutes

Secondary Outcomes (22)

• Uterine Tone baseline

  1 minute

• Uterine Tone 5 minutes

  5 minutes

• Uterine Tone 15 minutes

  15 minutes

• Uterine Tone 20 minutes

  20 minutes

• Additional uterotonic agents required intraoperatively

  90 minutes

Study Arms (2)

Calcium

ACTIVE COMPARATOR

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

Drug: Calcium Chloride; Drug: Carbetocin

Placebo

PLACEBO COMPARATOR

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

Other: Placebo; Drug: Carbetocin

Interventions

Placebo OTHER

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

Placebo

Carbetocin DRUG

50 mcg intravenous carbetocin.

Calcium; Placebo

Calcium Chloride DRUG

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

Calcium

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Calcium Chloride; carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mrinalini Balki, MD

CONTACT

416-586-4800; mrinalini.balki@uhn.ca

Kristi Downey, MSc

CONTACT

416-586-4800; kristi.downey@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 23, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)