Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
Mount Sinai Hospital
RECRUITING
Toronto
Contact Information
Primary
Mrinalini Balki, MD
mrinalini.balki@uhn.ca
416-586-4800
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2025-12
Participants
Target number of participants: 160
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

This content was sourced from clinicaltrials.gov