Postpartum Hemorrhage (Primary)NCT07187544
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
A study testing Calcium Chloride and Carbetocin in people with Postpartum Hemorrhage (Primary), run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage (Primary)
- What is being tested?
- Calcium Chloride and Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Mrinalini Balki, MD, 416-586-4800 ext. 5270, mrinalini.balki@uhn.ca
Ronald George, MD
About this study
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
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)
- Being tested
- Calcium Chloride, Placebo, Carbetocin
- Keywords
- calcium, carbetocin, cesarean
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium ChlorideDrug
Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.
PlaceboOther
Intravenous administration of 100ml normal saline, over 10 minutes.
CarbetocinDrug
50 mcg intravenous carbetocin.
| Study group | Role | What they receive |
|---|---|---|
| Calcium | Active comparator | Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes. Receives: Drug: Calcium Chloride; Drug: Carbetocin |
| Placebo | Placebo comparator | Intravenous administration of 100ml normal saline, over 10 minutes. Receives: Other: Placebo; Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (22)
Uterine Tone baseline
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.
Measured: 1 minute
Uterine Tone 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.
Measured: 5 minutes
Uterine Tone 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.
Measured: 15 minutes
Uterine Tone 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.
Measured: 20 minutes
Additional uterotonic agents required intraoperatively
The number of patients who are administered additional uterotonic agents intraoperatively will be recorded
Measured: 90 minutes
Additional uterotonic agents required post-operatively
The number of patients who are administered additional uterotonic agents post-operatively will be recorded
Measured: 24 hours
Semi-quantitative blood loss (SQBL)
Blood loss measured in the operating room by volume (ml)
Measured: 90 minutes
Incidence of postpartum hemorrhage
The number of patients with blood loss greater than or equal to 1000ml
Measured: 24 hours
Presence of blood transfusion
Number of units of blood product administered post-delivery
Measured: 24 hours
Number of patients with conservative surgical methods to manage post partum hemorrhage
Bakri balloon/B-Lynch sutures used intraoperatively
Measured: 2 hours
Number of patients with radiological methods used to manage post partum hemorrhage
Uterine artery embolization used intraoperatively.
Measured: 2 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
ObsQoR-10 score at 24 hours. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.
Measured: 24 hours
Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline
Systolic blood pressure < 80% of baseline, at any time during surgeryTime
Measured: 2 hours
Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline
Systolic blood pressure > 120% of baseline, at any time during surgery
Measured: 2 hours
Number of patients with tachycardia defined as heart rate greater than 130% of baseline
Heart rate > 130% of baseline, at any time during surgery
Measured: 2 hours
Number of patients with bradycardia defined as heart rate less than 70% of baseline
Heart rate < 70% of baseline, at any time during surgery
Measured: 2 hours
Presence of atrial fibrillation: ECG
Presence of atrial fibrillation as recorded by ECG, at any time during surgery
Measured: 2 hours
Presence of atrial flutter: ECG
Presence of atrial flutter as recorded by ECG, at any time during surgery
Measured: 2 hours
Presence of nausea: questionnaire
The presence of nausea at any time during surgery, as reported by the patient
Measured: 2 hours
Presence of vomiting: questionnaire
The presence of vomiting at any time during surgery, as reported by the patient
Measured: 2 hours
Number of patients with chest pain: questionnaire
Any presence of chest pain, at any time during surgery, as reported by the patient
Measured: 2 hours
Number of patients with irritation at the intravenous site: questionnaire
Any presence of irritation, including pain or burning, at the intravenous site, at any time during surgery, as reported by the patient.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Hemorrhage (Primary)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mrinalini Balki, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187544
- Sponsor's protocol ID
- 25-02
- Other IDs
- 300140
- Status last verified
- Feb 2026
- First submitted
- 15 Sep 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07187544
- Acronym / sponsor ID
- 25-02
- Conditions
- Postpartum Hemorrhage (Primary)
- Keywords
- calcium, carbetocin, cesarean
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium | Active comparator | Drug: Calcium Chloride, Drug: CarbetocinIntravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes. |
| Placebo | Placebo comparator | Other: Placebo, Drug: CarbetocinIntravenous administration of 100ml normal saline, over 10 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- Risk factors for uterine atony including:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium ChlorideIntravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes. | Drug | Calcium |
| PlaceboIntravenous administration of 100ml normal saline, over 10 minutes. | Other | Placebo |
| Carbetocin50 mcg intravenous carbetocin. | Drug | Calcium, Placebo |
Primary outcome
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.
22 secondary outcomes
Uterine Tone baseline
Time frame: 1 minute
Uterine Tone 5 minutes
Time frame: 5 minutes
Uterine Tone 15 minutes
Time frame: 15 minutes
Uterine Tone 20 minutes
Time frame: 20 minutes
Additional uterotonic agents required intraoperatively
Time frame: 90 minutes
Additional uterotonic agents required post-operatively
Time frame: 24 hours
Semi-quantitative blood loss (SQBL)
Time frame: 90 minutes
Incidence of postpartum hemorrhage
Time frame: 24 hours
Presence of blood transfusion
Time frame: 24 hours
Number of patients with conservative surgical methods to manage post partum hemorrhage
Time frame: 2 hours
Number of patients with radiological methods used to manage post partum hemorrhage
Time frame: 2 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
Time frame: 24 hours
Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline
Time frame: 2 hours
Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline
Time frame: 2 hours
Number of patients with tachycardia defined as heart rate greater than 130% of baseline
Time frame: 2 hours
Number of patients with bradycardia defined as heart rate less than 70% of baseline
Time frame: 2 hours
Presence of atrial fibrillation: ECG
Time frame: 2 hours
Presence of atrial flutter: ECG
Time frame: 2 hours
Presence of nausea: questionnaire
Time frame: 2 hours
Presence of vomiting: questionnaire
Time frame: 2 hours
Number of patients with chest pain: questionnaire
Time frame: 2 hours
Number of patients with irritation at the intravenous site: questionnaire
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mrinalini Balki, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Chloride and Carbetocin in people with Postpartum Hemorrhage (Primary), run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mrinalini Balki, MD (416-586-4800 ext. 5270, mrinalini.balki@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine Tone 10 minutes (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.