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Post Partum HemorrhageNCT04902729

Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity

A study testing Carbetocin and Oxytocin in people with Post Partum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postpartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug for the active management of third stage labor, to reduce the risk of PPH and help deliver the placenta. 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?
Carbetocin and Oxytocin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteCanada
Study dates
20 Jul 2021to 9 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

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

  • BMI≥40 kg/m2
  • Elective cesarean delivery under spinal, epidural, or combined spinal-epidural anaesthesia
  • Written informed consent
  • Full term pregnancy (37+0 to 40+6 weeks gestation)
  • Non-labouring patients

Who cannot join

  • Refusal to give written informed consent
  • Allergy or hypersensitivity to carbetocin or oxytocin
  • Laboring patients
  • Need for general anaesthesia
  • Conditions that predispose to uterine atony and postpartum haemorrhage including but not limited to:
  • Placenta previa
Show all 14Show fewer
  • Multiple gestations
  • Preeclampsia
  • Eclampsia
  • Polyhydramnios
  • Uterine fibroids
  • Previous history of uterine atony and postpartum bleeding
  • Bleeding diathesis
  • Hepatic, renal, and cardiovascular disease

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Mount Sinai Hospital

    Toronto, Ontario, M5G1X5

Other trials in Canada

About this study

Official title: Oxytocin Vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity: Double-blind, Randomised Control, Non-inferiority Trial

Postpartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug for the active management of third stage labor, to reduce the risk of PPH and help deliver the placenta. Carbetocin is currently recommended by the SOGC (Society of Obstetricans \& Gynecologists of Canada), and is a relatively newer drug with a longer duration of action. It has been previously demonstrated that women with elevated BMI require higher doses of these drugs to induce adequate uterine contraction and dose finding studies undertaken at Mount Sinai Hospital have shown that the ED 90 in obese patients to be carbetocin 80 mcg and oxytocin 1IU. Furthermore, previous studies have indicated that the use of carbetocin over oxytocin in non-obese popultion is associated with reduced bleeding and requirement of additional uterotonic medications. No study has directly compared the two drugs in obese parturients in a head to head clinical trial; therefore a double-blind randomized controlled trial is necessary to show the non-inferiority of carbetocin against the current standard of care at Mount Sinai hospital, which is oxytocin.

Read the detailed description

Obesity in pregnancy is defined as a Body Mass Index (BMI) above 30 kg/m2 and is often cited as a risk factor for PPH after cesarean delivery.

The World Health organization (WHO) recommends that uterotonic medications are routinely administered at cesarean delivery for the active management of the third stage of labor, both to facilitate delivery of the placenta and to reduce the risk of PPH. The optimal regimen for active management of third stage of labor is yet to be fully determined and obesity adds another layer of complexity and risk, with higher doses required to induce adequate uterine contraction. While oxytocin is the most commonly used drug world-wide, multiple agents are available and there is no clear consensus as to which drug should be first choice. Multiple studies have shown that carbetocin is associated with reduced post-partum bleeding, need for blood transfusion and additional uterotonic medications, in the non-obese population.

The results of this study will provide evidence on the non-inferiority of carbetocin when compared directly to the current standard of care at Mount Sinai hospital, which is oxytocin.

The investigators hypothesize that when administered in equipotent doses, carbetocin would be non-inferior to oxytocin in women with BMI ≥40 kg/m2 undergoing elective cesarean delivery.

The investigators hope to prove that the difference between uterine tone elicited by carbetocin falls within the inferiority margin of -1.2 using a verbal numerical rating score.

Being tested
Carbetocin, Oxytocin
Keywords
pregnancy, postpartum hemorrhage, cesarean delivery, carbetocin, duratocin, oxytocin
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarbetocinDrug

    Also called Duratocin

    Patient is given carbetocin (80mcg) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

  • OxytocinDrug

    Also called Pitocin

    Patient is given oxytocin (1IU) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby, followed by infusion 80 mU/min (40 IU in 1L given at a rate of 120 mL/h).

Study groups in NCT04902729
Study groupRoleWhat they receive
Oxytocin 1IUActive comparatorOxytocin 1IU, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby, followed by infusion 80 mU/min (40 IU in 1L given at a rate of 120 mL/h).
Receives: Drug: Oxytocin
Carbetocin 80mcgActive comparatorCarbetocin 80mcg, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.
Receives: Drug: Carbetocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uterine Tone 3 minutes

    The primary outcome will be 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, utilising a VNRS scale of 0-10.

    Measured: 3 minutes

Secondary outcomes (20)

  1. Uterine Tone 5 minutes

    Intensity of uterine tone on a VNRS scale of 0-10 as evaluated by the obstetrician at 5 minutes after completion of injection of the bolus study drug.

    Measured: 5 min

  2. Uterine Tone 10 minutes

    Intensity of uterine tone on a VNRS scale of 0-10 as evaluated by the obstetrician at 10 minutes after completion of injection of the bolus study drug.

    Measured: 10 min

  3. Additional uterotonics - operating room

    The use of additional uterotonic agents in the operating room

    Measured: 1-2 hours, length of surgery will vary

  4. Additional uterotonics - Post Anesthesia Care Unit (PACU)

    The use of additional uterotonic agents at any time after admission to the recovery area (Post Anesthesia Care Unit (PACU)) until transfer to the post partum ward.

    Measured: 4 hours

  5. Additional uterotonics - 24 hours

    The use of additional uterotonic agents at any time after discharge from the recovery area (Post Anesthesia Care Unit (PACU)) and up to 24 hours post delivery

    Measured: 24 hours

  6. Estimated blood loss calculated

    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

  7. Estimated blood loss, visual estimate provided by the obstetrician

    Blood loss in ml, as reported by the obstetrician at the end of the surgery.

    Measured: 2 hours

  8. Hypotension: systolic blood pressure less than 80% of baseline

    Systolic blood pressure < 80% of baseline, from drug administration until end of surgery

    Measured: 2 hours

  9. Hypertension: systolic blood pressure greater than 120% of baseline

    Systolic blood pressure > 120% of baseline, from drug administration until end of surgery

    Measured: 2 hours

  10. Tachycardia: heart rate greater than 130% of baseline

    Heart rate > 130% of baseline, from drug administration until end of surgery

    Measured: 2 hours

  11. Bradycardia: heart rate less than 70% of baseline

    Heart rate < 70% of baseline, from drug administration until end of surgery

    Measured: 2 hours

  12. Presence of ventricular tachycardia: ECG

    Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery

    Measured: 2 hours

  13. Presence of atrial fibrillation: ECG

    Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery

    Measured: 2 hours

  14. Presence of atrial flutter: ECG

    Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery

    Measured: 2 hours

  15. Presence of nausea: questionnaire

    The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient

    Measured: 2 hours

  16. Presence of vomiting: questionnaire

    The presence of vomiting and number of episodes, from drug administration until end of surgery

    Measured: 2 hours

  17. Presence of chest pain: questionnaire

    Any presence of chest pain, from drug administration until end of surgery, as reported by the patient

    Measured: 2 hours

  18. Presence of shortness of breath: questionnaire

    Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient

    Measured: 2 hours

  19. Presence of headache: questionnaire

    Any presence of headache, from drug administration until end of surgery, as reported by the patient

    Measured: 2 hours

  20. Presence of flushing: questionnaire

    Any presence of flushing, from drug administration until end of surgery

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2021
  2. Study start20 Jul 2021
  3. Primary completion8 Dec 2022
  4. Study completion9 Dec 2022

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04902729
Sponsor's protocol ID
21-03
Status last verified
Feb 2023
First submitted
21 May 2021
Last updated
23 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Turner W, Boonstra L, Maxwell C, Downey K, Balki M. Oxytocin versus carbetocin at elective Cesarean delivery in parturients with class III obesity: a double-blind randomized controlled noninferiority trial. Can J Anaesth. 2025 Mar;72(3):426-435. doi: 10.1007/s12630-024-02891-2. Epub 2025 Jan 6.

    PubMed 39760981

Questions about this trial

What is this clinical trial studying?

A study testing Carbetocin and Oxytocin 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 23 Feb 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uterine Tone 3 minutes (time frame: 3 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04902729, which also lists 1 linked publication.

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 23 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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