Clinical trial NCT01579201: ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery
Official title: ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Uterine Atony
Keywords: Postpartum Hemorrhage
Uterine Atony
Obstetric Anesthesia
Cesarean Section
Carbetocin
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
Collaborators: name: Université de Montréal
First posted: 2012-04-17
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women (ASA I or II)
* Elective cesarean delivery
* Spinal anesthesia
* Term gestation (37 weeks and above)

Exclusion Criteria:

* Multiple gestation
* Known coagulopathy
* Active labour
* Uterine fibroids
* Body mass index \> 45
* Emergency cesarean section
* General anesthesia
* Any contraindication to neuraxial anesthesia
* Cardiopathies
* Known allergies to carbetocin
* Patient refusal
* Placenta previa/Placenta accreta
* Hypertensive disease/Preeclampsia/Eclampsia
* Polyhydramnios
* Previous history of uterine atony or postpartum hemorrhage
* Renal or liver disease

Primary outcomes:
measure: Dose of carbetocin which will prevent uterine atony in 90% of subjects
timeFrame: 5 minutes
Secondary outcomes:
measure: Incidence of side effects
timeFrame: 20 minutes
measure: Vasopressors administered
timeFrame: 20 minutes
measure: Anti nausea therapy
timeFrame: 20 minutes
measure: Additional uterotonic medication administered
timeFrame: 20 minutes
measure: Additional uterine massage
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Christian Loubert, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: