Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
160 participants
Jan 14, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria5
- Valvular heart disease, arrhythmias, or heart failure
- Placenta accreta spectrum
- Bleeding disorder
- Anemia (\<100 g/dl)
- Allergy or sensitivity to oxytocin or carbetocin
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Interventions
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.
Patient is given carbetocin 100 mcg diluted in 10 mL normal saline, administered intravenously over 1 min, followed by placebo infusion for 4 hours.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06333340