Recruiting

Carbetocin vs. Oxytocin

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT06333340

Conditions

Post Partum Hemorrhage

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Oxytocin

Carbetocin

Study Details

Brief 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. 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.

Conditions

Post Partum Hemorrhage

Study ID

NCT06333340

Start date

Jan 14, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion criteria - Any one or more of the risk factors for uterine atony:

  • Overdistended uterus due to:

  • Polyhydramnios (amniotic fluid index >24 cm)
  • Fetal macrosomia reported on prenatal ultrasound >90th centile or > 4000 gm
  • Multiple gestation
  • History of uterine atony/PPH (documented with blood loss of >1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)
  • Obesity with body mass index (BMI) >40 kg/m2
  • Diabetes mellitus on treatment
  • Preeclampsia on treatment
  • Placenta previa

Exclusion criteria:

  • Valvular heart disease, arrhythmias, or heart failure
  • Placenta accreta spectrum
  • Bleeding disorder
  • Anemia (<100 g/dl)
  • Allergy or sensitivity to oxytocin or carbetocin

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Oxytocin 5IU

IV oxytocin 5 IU diluted in 10 mL normal saline over 1 min followed by continuous infusion of 250 mIU/min over 4 hours.

active comparator: Carbetocin 100mcg

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.

Interventions

Oxytocin

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.

Carbetocin

Patient is given carbetocin 100 mcg diluted in 10 mL normal saline, administered intravenously over 1 min, followed by placebo infusion for 4 hours.

Primary outcome measure

  • Proportion of parturients requiring additional uterotonic agents intraoperatively [ Time Frame: 90 minutes ]

Central Contacts and Locations

Central contacts

Mrinalini Balki, MD

416-586-4800mrinalini.balki@uhn.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

Mrinalini Balki, MD

416-586-4800mrinalini.balki@uhn.ca

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Apr 1, 2026

Last verified

Feb, 2026

Keywords

  • oxytocin
  • carbetocin
  • cesarean delivery
  • pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2026-04-01.