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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

Valvular heart disease, arrhythmias, or heart failure

Placenta accreta spectrum

Bleeding disorder

Anemia (<100 g/dl)

Trial design

Treatments tested in this trial

  • Oxytocin
  • Carbetocin

Treatment groups

160 Participants
are divided into 2 treatment groups