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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Treatments: Carbetocin; Oxytocin

Criteria

Inclusion Criteria:

• BMI ≥40kg/m2

• Elective cesarean delivery under regional anesthesia

• Gestational age ≥ 37 weeks

• No known additional risk factors for postpartum hemorrhage

• Written informed consent to participate in this study

Exclusion Criteria:

• Refusal to give written informed consent

• Allergy or hypersensitivity to carbetocin or oxytocin

• Conditions (other than high BMI) that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.

• Hepatic, renal, and vascular disease

• Use of general anesthesia prior to the administration of the study drug