Status:
COMPLETED
Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions:
Post Partum Hemorrhage
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief 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 a...
Detailed Description
Obesity in pregnancy is defined as a Body Mass Index (BMI) above 30 kg/m2 and is often cited as a risk factor for PPH after cesarean delivery. The World Health organization (WHO) recommends that uter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04902729
Start Date
July 20 2021
End Date
December 9 2022
Last Update
February 23 2023
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5