Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• 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≥40 kg/m2

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

• Written informed consent

• Full term pregnancy (37+0 to 40+6 weeks gestation)

• Non-labouring patients

Exclusion Criteria:

• Refusal to give written informed consent

• Allergy or hypersensitivity to carbetocin or oxytocin

• Laboring patients

• Need for general anaesthesia

• Conditions that predispose to uterine atony and postpartum haemorrhage including but not limited to:

• Placenta previa

• Multiple gestations

• Preeclampsia

• Eclampsia

• Polyhydramnios

• Uterine fibroids

• Previous history of uterine atony and postpartum bleeding

• Bleeding diathesis

• Hepatic, renal, and cardiovascular disease