DRUG
Calcium Chloride
Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Status
Recruiting
Phase
Not applicable
Enrollment
120
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
OTHER
Placebo
Intravenous administration of 100ml normal saline, over 10 minutes.
DRUG
Carbetocin
50 mcg intravenous carbetocin.
Timeline
From registration to results.
First posted
Sep 23, 2025
Study start
Dec 1, 2025
Primary completion
Dec 2026
Study completion
Dec 2026
Results posted
Not reported
Registry updated
Apr 1, 2026
Outcomes
What the study measures.
Primary outcomes
Uterine Tone 10 minutes
Time frame · 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.
Secondary outcomes
Uterine Tone baseline
Time frame · 1 minute
The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician after delivery of the placenta, utilizing a verbal numeric rating scale of 0-10.
Uterine Tone 5 minutes
Time frame · 5 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.
Uterine Tone 15 minutes
Time frame · 15 minutes
The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 15 minutes post-fetal delivery, utilizing a verbal numeric rating scale of 0-10.
Uterine Tone 20 minutes
Time frame · 20 minutes
The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 20 minutes post-fetal delivery, utilizing a verbal numeric rating scale of 0-10.
Additional uterotonic agents required intraoperatively
Time frame · 90 minutes
The number of patients who are administered additional uterotonic agents intraoperatively will be recorded
Additional uterotonic agents required post-operatively
Time frame · 24 hours
The number of patients who are administered additional uterotonic agents post-operatively will be recorded
Semi-quantitative blood loss (SQBL)
Time frame · 90 minutes
Blood loss measured in the operating room by volume (ml)
Incidence of postpartum hemorrhage
Time frame · 24 hours
The number of patients with blood loss greater than or equal to 1000ml
Presence of blood transfusion
Time frame · 24 hours
Number of units of blood product administered post-delivery
Number of patients with conservative surgical methods to manage post partum hemorrhage
Time frame · 2 hours
Bakri balloon/B-Lynch sutures used intraoperatively
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Scheduled CD for patients ≥ 37 weeks excluding high risk factors for uterine atony 2. Neuraxial anesthesia as the primary anesthetic where intrathecal medications are the primary anesthetic Exclusion Criteria: 1. Risk factors for uterine atony including: 1. 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 2. 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) 3. Obesity with body mass index (BMI) \> 40 kg/m2 4. Placenta previa and/or placenta accreta 2. Digoxin therapy within 14 days (hypercalcemia can exacerbate digoxin toxicity) 3. Patients needing intraoperative IV ceftriaxone or tetracycline. 4. 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) 5. Calcium channel blockade within 24 hours (opposing effect) 6. Known history of cardiac disease including arrhythmias, ischemia, and congenital heart disease (to avoid attributing cardiac symptoms to study drugs) 7. Preexisting hypertension, preeclampsia or persistent elevated blood pressure above 160/100 mmHg requiring treatment 8. Emergency cesarean deliveries or women in labor 9. Planned general anesthetic for patients where neuraxial is contraindicated.
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Mount Sinai Hospital
Toronto, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Carbetocin.
NCT IDStudyPhase / statusEnrollmentUpdated
The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy
Alex Ekwueme Federal University Teaching Hospital · Blood Loss, Surgical
Early Phase 1
Not yet recruiting
900
2026-07
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Mansoura University · Postpartum Hemorrhage · Uterine Atony
Phase 4
Not yet recruiting
332
2026-06
Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage
Sheba Medical Center · Postpartum Hemorrhage · Twin Pregnancy
Phase 4
Recruiting
120
2026-05
Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage
Not applicable
Recruiting
32
2026-04
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Post Partum Hemorrhage
Not applicable
Recruiting
160
2026-04
Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients
Ankara Etlik City Hospital · Postpartum Hemorrhage \(PPH\)
Not applicable
Completed
300
2026-02
Carbetocin Myocardium Trial 2014 Part 2
Oslo University Hospital · Pregnancy Complications
Phase 4
Completed
240
2026-02
Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy
Cairo University · Myoma;Uterus
Not applicable
Recruiting
40
2026-02
Related PeptideStat pages
Put the record in context.
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