Postpartum Hemorrhage Clinical Trial
Official title:
ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery
The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.
Postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide.
Carbetocin have been shown effective in the prevention of uterine atony, which is the
leading cause of postpartum hemorrhage. The Society of Obstetricians and Gynecologists of
Canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to
prevent postpartum hemorrhage. However, there is no clear data in the literature regarding
the lowest effective dose of carbetocin that should be administered. The use of the minimum
effective dose of carbetocin may reduce its side effects, including hypotension,
tachycardia, nausea, vomiting and flushing.
In this trial, healthy term pregnant women undergoing elective cesarean delivery under
spinal anesthesia will be recruited. The effective dose of carbetocin that will prevent
postpartum uterine atony in 90% of the women (ED90) will be determined using a biased coin
design up-down sequential allocation method. The determination of the carbetocin ED90 will
help the anesthesiologist regarding the optimal dose of carbetocin to administer after
elective cesarean delivery to prevent uterine atony.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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