Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2
Status:
Completed
Trial end date:
2019-05-17
Target enrollment:
Participant gender:
Summary
Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and
mortality. Carbetocin is a uterotonic with a superior pharmacokinetic profile to oxytocin. In
a study performed at Mount Sinai Hospital, the investigators have shown that smaller doses of
carbetocin (14.8 mcg) are as effective in achieving adequate uterine tone at elective
cesarean section compared to the current recommended dose of 100mcg. However, this study was
limited to those women with a body mass index (BMI) of <40 kg/m2. Maternal obesity has been
shown to increase the risks of hemorrhage secondary to uterine atony, therefore the
investigators wish to perform a dose finding study to determine the ED90 of carbetocin at
caesarean section in those women with a BMI>40.
Phase:
N/A
Details
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital