drugset / Trial / NCT04902729

Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity

NCT04902729

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2021-07-20
Primary completion
2022-12-08
Completion
2022-12-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carbetocin Peptide 80 ug Intravenous
Comparator Oxytocin Peptide 4.8 iu Intravenous

Indications

No indication recorded.