Post-partum Hemorrhage, Uterine Atony
Conditions
Keywords
Carbetocin, Uterotonic drug, elective cesarean section
Brief summary
The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.
Detailed description
Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section. Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.
Interventions
DRUGCarbetocin
Administration of carbetocin 50 mcg , after clamping the umbilical cord
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years old * ≥ 37-week pregnancy * singleton pregnancy * elective cesarean section with a low transverse incision * ASA I or II
Exclusion criteria
* Personal history of uterine atony or postpartum hemorrhage * Abnormal placental implantation (known or suspected) * \> 3 cesarean sections in the past * Personal history of a classic uterine incision * Estimated fetal weight \> 4500g * Hemoglobin \< 100 g/L * Regular use of tocolytic drugs * Cesarean section under general anesthesia * Known allergy to carbetocin * Refusal * Inability to obtain informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Utilization of a second uterotonic drug | First 48 hours of the postpartum |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of side effects | During the fifteen minutes following the administration of carbetocin |
| Incidence of major complications | First 48 hours of the postpartum |
| Drop in hemoglobin measurement | on the second post-partum day |
Countries
Canada
Outcome results
None listed