DRUG
Carbetocin
Patient is given carbetocin (80mcg) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.
Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity
Status
Completed
Phase
Not applicable
Enrollment
48
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Oxytocin
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).
Timeline
From registration to results.
First posted
May 26, 2021
Study start
Jul 20, 2021
Primary completion
Dec 8, 2022
Study completion
Dec 9, 2022
Results posted
Not reported
Registry updated
Feb 23, 2023
Outcomes
What the study measures.
Primary outcomes
Uterine Tone 3 minutes
Time frame · 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.
Secondary outcomes
Uterine Tone 5 minutes
Time frame · 5 min
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.
Uterine Tone 10 minutes
Time frame · 10 min
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.
Additional uterotonics - operating room
Time frame · 1-2 hours, length of surgery will vary
The use of additional uterotonic agents in the operating room
Additional uterotonics - Post Anesthesia Care Unit (PACU)
Time frame · 4 hours
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.
Additional uterotonics - 24 hours
Time frame · 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
Estimated blood loss calculated
Time frame · 24 hours
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.
Estimated blood loss, visual estimate provided by the obstetrician
Time frame · 2 hours
Blood loss in ml, as reported by the obstetrician at the end of the surgery.
Hypotension: systolic blood pressure less than 80% of baseline
Time frame · 2 hours
Systolic blood pressure \< 80% of baseline, from drug administration until end of surgery
Hypertension: systolic blood pressure greater than 120% of baseline
Time frame · 2 hours
Systolic blood pressure \> 120% of baseline, from drug administration until end of surgery
Tachycardia: heart rate greater than 130% of baseline
Time frame · 2 hours
Heart rate \> 130% of baseline, from drug administration until end of surgery
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Multiple gestations * Preeclampsia * Eclampsia * Polyhydramnios * Uterine fibroids * Previous history of uterine atony and postpartum bleeding * Bleeding diathesis * Hepatic, renal, and cardiovascular disease
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.
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
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage (Primary)
Not applicable
Recruiting
120
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
Related PeptideStat pages
Put the record in context.
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