Status:
COMPLETED
Impact of Carbetocin Administration on Heart Rate When Given as an Infusion Versus as a Bolus.
Lead Sponsor:
Ciusss de L'Est de l'Île de Montréal
Conditions:
Cesarean Section Complications
Hemodynamic Instability
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Prospective, randomized and controlled study who will be conducted at Maisonneuve-Rosemont hospital with the following objectives: To determine if an infusion of carbetocin over 10 minutes will reduc...
Detailed Description
The purpose of this prospective pragmatic study is to determine if an infusion of carbetocin over 10 minutes will reduce hemodynamic compromise in comparison to a rapid intravenous bolus (less than 2 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Elective caesarean delivery
- 37 weeks or more of gestation
- ASA status I or II
- Patients \> 18 years old
- Spinal anesthesia
- Non-Inclusion Criteria:
- Multiple gestation
- Morbid obesity (BMI \> 40 at first prenatal medical visit)
- Coagulopathy
- Active labour
- Polyhydramnios
- Leiomyoma/Uterine fibroma
- Hypotensive illness/Pre-eclampsia/Eclampsia
- Placenta accreta/Previa
- Cardiopathy of any kind
- Patient on medication affecting hemodynamics (ex. B-blocker, CCG, antihypertensive, etc)
- Emergent cesarean delivery
- Contra-indications to spinal anesthesia
- General anesthesia for cesarean delivery
- Known allergy to carbetocin
- Patient refusal
- Exclusion criteria
- Patient who receives iv ephedrine or glycopyrrolate during the study period
- Administration of a second dose of carbetocin or other uterotonic agent.
- Onset of post-partum hemorrhage defined as blood loss \> 1000 ml or uncontrolled bleeding after delivery of the baby.
- Patient who needs an exteriorization of the uterus for repair following caesarean delivery.
Exclusion
Key Trial Info
Start Date :
June 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03404544
Start Date
June 11 2018
End Date
January 15 2021
Last Update
October 4 2021
Active Locations (1)
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1
CIUSSS de l'Est de l'Ile de Montreal
Montreal, Quebec, Canada, H1T2M4