Clinical trial NCT01428817: Carbetocin at Elective Cesarean Delivery Part 2
Official title: Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: pregnancy
postpartum hemorrhage
Cesarean delivery
carbetocin
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.

Detailed description: The Society of Obstetricians and Gynecologists of Canada (SOGC) recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery.

Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effect profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin. A dose response study conducted by Cordovani et al suggested no difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg. Additionally, hypotension was noted for all dose groups studied.

The results of this follow-up study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.

Eligibility criteria: Inclusion Criteria:

* All patients planned for elective cesarean delivery under spinal anesthesia.
* All patients who give written informed consent to participate in this study.

Exclusion Criteria:

* All patients who refuse to give written informed consent.
* All patients who claim allergy or hypersensitivity to carbetocin or oxytocin.
* All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
* All patients with hepatic, renal, and vascular disease,
* All patients requiring general anesthesia prior to the administration of the study drug.

Primary outcomes:
measure: Uterine tone
timeFrame: 2 minutes
Secondary outcomes:
measure: Uterine tone
timeFrame: 2 hours
measure: Blood loss
timeFrame: 48 hours
measure: Side effects
timeFrame: 2 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose CA Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anandakrishnan S, Balki M, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose, part 2. Can J Anaesth. 2013 Nov;60(11):1054-60. doi: 10.1007/s12630-013-0028-2. Epub 2013 Sep 25.