Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity

Recruiting in Palo Alto (17 mi)

Overseen byMrinalini Balki, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?Postpartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug for the active management of third stage labor, to reduce the risk of PPH and help deliver the placenta. Carbetocin is currently recommended by the SOGC (Society of Obstetricans \& Gynecologists of Canada), and is a relatively newer drug with a longer duration of action. It has been previously demonstrated that women with elevated BMI require higher doses of these drugs to induce adequate uterine contraction and dose finding studies undertaken at Mount Sinai Hospital have shown that the ED 90 in obese patients to be carbetocin 80 mcg and oxytocin 1IU. Furthermore, previous studies have indicated that the use of carbetocin over oxytocin in non-obese popultion is associated with reduced bleeding and requirement of additional uterotonic medications. No study has directly compared the two drugs in obese parturients in a head to head clinical trial; therefore a double-blind randomized controlled trial is necessary to show the non-inferiority of carbetocin against the current standard of care at Mount Sinai hospital, which is oxytocin.

Eligibility Criteria

Inclusion Criteria

BMI≥40 kg/m2

Elective cesarean delivery under spinal, epidural, or combined spinal-epidural anaesthesia

Written informed consent

+2 more

Participant Groups

2Treatment groups

Active Control

Group I: Carbetocin 80mcgActive Control1 Intervention

Carbetocin 80mcg, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Group II: Oxytocin 1IUActive Control1 Intervention

Oxytocin 1IU, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby, followed by infusion 80 mU/min (40 IU in 1L given at a rate of 120 mL/h).