ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 13, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 15, 2013
February 1, 2013
1 year
April 13, 2012
February 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose of carbetocin which will prevent uterine atony in 90% of subjects
The uterine tone will be assessed by the obstetrician by palpation 5 minutes after injection. The uterine tone will be judged either as satisfactory or unsatisfactory.
5 minutes
Secondary Outcomes (5)
Incidence of side effects
20 minutes
Vasopressors administered
20 minutes
Anti nausea therapy
20 minutes
Additional uterotonic medication administered
20 minutes
Additional uterine massage
20 minutes
Study Arms (1)
Carbetocin
EXPERIMENTALInterventions
First patient: 70 mcg. Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg. An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change.
Eligibility Criteria
You may qualify if:
- Healthy pregnant women (ASA I or II)
- Elective cesarean delivery
- Spinal anesthesia
- Term gestation (37 weeks and above)
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maisonneuve-Rosemont Hospitallead
- Université de Montréalcollaborator
Study Sites (1)
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Loubert, MD, FRCPC
Maisonneuve-Rosemont Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Christian Loubert, MD, FRCPC
Study Record Dates
First Submitted
April 13, 2012
First Posted
April 17, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 15, 2013
Record last verified: 2013-02