Post Partum HemorrhageNCT06333340
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
A study testing Oxytocin and Carbetocin in people with Post Partum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Oxytocin and Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Valvular heart disease, arrhythmias, or heart failure
- Placenta accreta spectrum
- Bleeding disorder
- Anemia (<100 g/dl)
- Allergy or sensitivity to oxytocin or carbetocin
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
Narinder Singh, MD
About this study
Official title: Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial
The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.
This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.
The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.
Read the detailed description
Postpartum hemorrhage (PPH) is a potentially life-threatening complication and one of the leading causes of maternal mortality. It has been estimated that one in every five maternal deaths occurs due to PPH globally. Primary PPH is predominantly caused by uterine atony or inadequate contraction of the uterus after childbirth. Active management of the third stage of labor involves prophylactic administration of a uterotonic agent before delivery of the placenta, as well as delayed cord clamping and controlled traction of the umbilical cord. The uterotonic administration remains the most essential component in terms of preventing PPH.
Oxytocin, a synthetic pituitary hormone, is the most commonly used first-line uterotonic drug. However, because of the short half-life (3-17 min), a continuous intravenous infusion is necessary to maintain uterotonic activity. Carbetocin is a synthetic oxytocin analog that binds with a similar affinity to the oxytocin receptors in the myometrium. Carbetocin produces stronger and more sustained action compared to oxytocin and has a longer half-life than oxytocin, thus reducing the requirement for an infusion after the initial dose. Recently published guidelines from the Society of Obstetrics and Gynecology (SOGC) have stated that Carbetocin should be considered as a first-line agent for the prevention of PPH after cesarean delivery (CD). The international consensus statement on the use of uterotonic agents has also recommended carbetocin as an alternative to oxytocin infusion during CD due to its longer duration of action.
Trials comparing carbetocin with oxytocin in CD have shown mixed results on superiority of carbetocin over oxytocin for the need for additional uterotonics and amount of blood loss, however, no significant effect on blood loss >1000 ml could be found. Most of the trials evaluating the prophylactic role of oxytocin and carbetocin after CD have focused on the low-risk PPH population. The incidence of biological risk factors for uterine atony such as multiple gestation (due to assisted reproductive techniques), and obesity has progressively increased in developed countries. There is still a lack of high-quality trials on the efficacy of carbetocin in high-risk parturients undergoing CD.
In this study, the investigators aim to compare the efficacy of carbetocin 100 mcg with oxytocin 5 IU bolus followed by continuous infusion of 250 mIU/min over 4 hours at elective CD in parturients with risk factors for uterine atony.
The comparative data is still lacking for both the agents as first-line uterotonics for patients having a high risk for uterine atony undergoing cesarean delivery. The result of this trial regarding the relative uterotonic efficacy and safety of the standardized prophylactic doses of both agents (carbetocin and oxytocin) will form the evidence base for future guidelines in high-risk parturients.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Oxytocin, Carbetocin
- Keywords
- oxytocin, carbetocin, cesarean delivery, pregnancy
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Patient is given oxytocin 5 IU diluted in 10 mL normal saline, administered intravenously over 1 min, followed by continuous infusion of 250 mIU/min over 4 hours.
CarbetocinDrug
Also called Duratocin
Patient is given carbetocin 100 mcg diluted in 10 mL normal saline, administered intravenously over 1 min, followed by placebo infusion for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin 5IU | Active comparator | IV oxytocin 5 IU diluted in 10 mL normal saline over 1 min followed by continuous infusion of 250 mIU/min over 4 hours. Receives: Drug: Oxytocin |
| Carbetocin 100mcg | Active comparator | IV carbetocin 100 mcg diluted in 10 mL normal saline over 1 min followed by placebo infusion for 4 hours after the delivery of the fetus. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of parturients requiring additional uterotonic agents intraoperatively
The proportion of patients who are administered additional uterotonic agents intraoperatively will be divided by the total number of patients assigned to the same treatment arm, for each of the 2 groups: oxytocin and carbetocin.
Measured: 90 minutes
Secondary outcomes (25)
Uterine Tone 3 minutes
The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 3 minutes, from the completion of delivery of the drug, utilizing a verbal numeric rating scale of 0-10.
Measured: 3 minutes
Uterine Tone 5 minutes
The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 5 minutes, from the completion of delivery of the drug, utilizing a verbal numeric rating scale of 0-10.
Measured: 5 minutes
Uterine Tone 10 minutes
The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 10 minutes, from the completion of delivery of the drug, utilizing a verbal numeric rating scale of 0-10.
Measured: 10 minutes
Calculated blood loss (CBL)
Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 24 hours after the cesarean section.
Measured: 24 hours
Semi-quantitative blood loss (SQBL)
Blood loss measured in the operating room by volume (ml)
Measured: 2 hours
Presence of blood transfusion
Number of units of blood product administered post-delivery
Measured: 24 hours
Number of patients with ICU admission
Admission to the intensive care unit for bleeding post partum
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
Number of patients with surgical post partum hemorrhage management measures
Re-exploration for bleeding/uterine artery ligation/hysterectomy
Measured: 2 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 surgery
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 ventricular tachycardia: ECG
Presence of ventricular tachycardia as recorded by ECG, 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 shortness of breath: questionnaire
Any presence of shortness of breath, at any time during surgery, as reported by the patient.
Measured: 2 hours
Number of patients with headache: questionnaire
Any presence of headache, at any time during surgery, as reported by the patient.
Measured: 2 hours
Number of patients with flushing: questionnaire
Any presence of flushing, at any time during surgery.
Measured: 2 hours
Additional uterotonics administered up to 24 hours post delivery: questionnaire
Were any additional uterotonics administered up to 24 hours post delivery: yes or no Detailed description of any medication and dosage recorded.
Measured: 24 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start14 Jan 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 Post Partum HemorrhageStudies 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
- 160 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
- NCT06333340
- Sponsor's protocol ID
- 24-03
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2024
- 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
- Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06333340
- Acronym / sponsor ID
- 24-03
- Conditions
- Post Partum Hemorrhage
- Keywords
- oxytocin, carbetocin, cesarean delivery, pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Mar 2024 (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.
The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.
This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.
The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.
Detailed description
Postpartum hemorrhage (PPH) is a potentially life-threatening complication and one of the leading causes of maternal mortality. It has been estimated that one in every five maternal deaths occurs due to PPH globally. Primary PPH is predominantly caused by uterine atony or inadequate contraction of the uterus after childbirth. Active management of the third stage of labor involves prophylactic administration of a uterotonic agent before delivery of the placenta, as well as delayed cord clamping and controlled traction of the umbilical cord. The uterotonic administration remains the most essential component in terms of preventing PPH.
Oxytocin, a synthetic pituitary hormone, is the most commonly used first-line uterotonic drug. However, because of the short half-life (3-17 min), a continuous intravenous infusion is necessary to maintain uterotonic activity. Carbetocin is a synthetic oxytocin analog that binds with a similar affinity to the oxytocin receptors in the myometrium. Carbetocin produces stronger and more sustained action compared to oxytocin and has a longer half-life than oxytocin, thus reducing the requirement for an infusion after the initial dose. Recently published guidelines from the Society of Obstetrics and Gynecology (SOGC) have stated that Carbetocin should be considered as a first-line agent for the prevention of PPH after cesarean delivery (CD). The international consensus statement on the use of uterotonic agents has also recommended carbetocin as an alternative to oxytocin infusion during CD due to its longer duration of action.
Trials comparing carbetocin with oxytocin in CD have shown mixed results on superiority of carbetocin over oxytocin for the need for additional uterotonics and amount of blood loss, however, no significant effect on blood loss >1000 ml could be found. Most of the trials evaluating the prophylactic role of oxytocin and carbetocin after CD have focused on the low-risk PPH population. The incidence of biological risk factors for uterine atony such as multiple gestation (due to assisted reproductive techniques), and obesity has progressively increased in developed countries. There is still a lack of high-quality trials on the efficacy of carbetocin in high-risk parturients undergoing CD.
In this study, the investigators aim to compare the efficacy of carbetocin 100 mcg with oxytocin 5 IU bolus followed by continuous infusion of 250 mIU/min over 4 hours at elective CD in parturients with risk factors for uterine atony.
The comparative data is still lacking for both the agents as first-line uterotonics for patients having a high risk for uterine atony undergoing cesarean delivery. The result of this trial regarding the relative uterotonic efficacy and safety of the standardized prophylactic doses of both agents (carbetocin and oxytocin) will form the evidence base for future guidelines in high-risk parturients.
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 |
|---|---|---|
| Oxytocin 5IU | Active comparator | Drug: OxytocinIV oxytocin 5 IU diluted in 10 mL normal saline over 1 min followed by continuous infusion of 250 mIU/min over 4 hours. |
| Carbetocin 100mcg | Active comparator | Drug: CarbetocinIV carbetocin 100 mcg diluted in 10 mL normal saline over 1 min followed by placebo infusion for 4 hours after the delivery of the fetus. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Valvular heart disease, arrhythmias, or heart failure
- Placenta accreta spectrum
- Bleeding disorder
- Anemia (<100 g/dl)
- Allergy or sensitivity to oxytocin or carbetocin
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 |
|---|---|---|
| OxytocinAlso: PitocinPatient is given oxytocin 5 IU diluted in 10 mL normal saline, administered intravenously over 1 min, followed by continuous infusion of 250 mIU/min over 4 hours. | Drug | Oxytocin 5IU |
| CarbetocinAlso: DuratocinPatient is given carbetocin 100 mcg diluted in 10 mL normal saline, administered intravenously over 1 min, followed by placebo infusion for 4 hours. | Drug | Carbetocin 100mcg |
Primary outcome
Proportion of parturients requiring additional uterotonic agents intraoperatively
Time frame: 90 minutes
The proportion of patients who are administered additional uterotonic agents intraoperatively will be divided by the total number of patients assigned to the same treatment arm, for each of the 2 groups: oxytocin and carbetocin.
25 secondary outcomes
Uterine Tone 3 minutes
Time frame: 3 minutes
Uterine Tone 5 minutes
Time frame: 5 minutes
Uterine Tone 10 minutes
Time frame: 10 minutes
Calculated blood loss (CBL)
Time frame: 24 hours
Semi-quantitative blood loss (SQBL)
Time frame: 2 hours
Presence of blood transfusion
Time frame: 24 hours
Number of patients with ICU admission
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
Number of patients with surgical post partum hemorrhage management measures
Time frame: 2 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 ventricular tachycardia: ECG
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 shortness of breath: questionnaire
Time frame: 2 hours
Number of patients with headache: questionnaire
Time frame: 2 hours
Number of patients with flushing: questionnaire
Time frame: 2 hours
Additional uterotonics administered up to 24 hours post delivery: questionnaire
Time frame: 24 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
Time frame: 24 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
Related trials for Post Partum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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 Oxytocin and Carbetocin in people with Post Partum Hemorrhage, 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 0 inclusion and 5 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. 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?
Proportion of parturients requiring additional uterotonic agents intraoperatively (time frame: 90 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.