drugset / Trial / NCT03672045

Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2

NCT03672045

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-11-19
Primary completion
2019-05-16
Completion
2019-05-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carbetocin Peptide 10 ug Intravenous
Comparator Carbetocin Peptide 20 ug Intravenous
Comparator Carbetocin Peptide 40 ug Intravenous
Comparator Carbetocin Peptide 60 ug Intravenous
Comparator Carbetocin Peptide 80 ug Intravenous
Comparator Carbetocin Peptide 100 ug Intravenous

Indications

No indication recorded.