Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy.
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Poor uterine tone after the birth of a baby can cause excess bleeding (called postpartum
hemorrhage or PPH). This is a major cause of maternal death worldwide. Uterotonic drugs are
used to improve the muscle tone of the uterus after birth, and these are effective at
reducing the incidence of PPH. The Society of Obstetricians and Gynecologists of Canada
(SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery
to promote uterine contraction. In a study performed at Mount Sinai Hospital, the
investigators have shown that smaller doses of carbetocin (14.8 mcg) are effective in
achieving adequate uterine tone at elective cesarean section.
In these dose-finding studies, women with multiple pregnancies have been excluded. Because
women with multiple pregnancy have a higher risk of severe PPH, uterine atony, hysterectomy,
prolonged hospital stay and death, it is plausible that a higher dose of carbetocin is
required. This question remains unanswered.
The hypothesis is that the ED90 of carbetocin in women with twin pregnancy undergoing
elective cesarean delivery under regional anesthesia is greater than 20 mcg but less than 100
mcg.
Phase:
N/A
Details
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital