Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Laval University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Utilization of a second uterotonic drug
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
- •Inability to obtain informed consent
Arms & Interventions
Carbetocin 100 mcg
Intervention: Carbetocin (Drug)
Carbetocin 50 mcg
Intervention: Carbetocin (Drug)
Outcomes
Primary Outcomes
Utilization of a second uterotonic drug
Time Frame: First 48 hours of the postpartum
Secondary Outcomes
- 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)