Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery

Launched by SAMUEL LUNENFELD RESEARCH INSTITUTE, MOUNT SINAI HOSPITAL · Mar 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two medications, carbetocin and oxytocin, which are used to help prevent severe bleeding after a cesarean delivery, a condition known as postpartum hemorrhage (PPH). The trial specifically focuses on women who are at a higher risk for PPH due to factors like having twins or more babies, a large baby, a history of heavy bleeding after childbirth, obesity, diabetes, high blood pressure, or certain placenta conditions. Researchers want to see if carbetocin is more effective than oxytocin in reducing the risk of PPH in these patients.

To be eligible for this study, women must have at least one of the mentioned risk factors. While participating, they will receive one of the two medications right after their cesarean delivery and will be monitored for any bleeding issues. It's important to note that women with certain heart conditions, bleeding disorders, or allergies to these medications cannot participate. This trial is actively recruiting participants and aims to provide valuable information on the best ways to prevent heavy bleeding in at-risk patients during and after cesarean deliveries.

Gender

FEMALE

Eligibility criteria

• 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