|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01579201 |
|
Date of registration:
|
13/04/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery
|
|
Scientific title:
|
ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery |
|
Date of first enrolment:
|
March 2012 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01579201 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Christian Loubert, MD, FRCPC |
|
Address:
|
|
|
Telephone:
|
514.252.3426 |
|
Email:
|
loubertch@yahoo.fr |
|
Affiliation:
|
|
|
|
Name:
|
Christian Loubert, MD, FRCPC |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Maisonneuve-Rosemont Hospital |
|
|
Name:
|
Christian Loubert, MD, FRCPC |
|
Address:
|
|
|
Telephone:
|
514.252.3426 |
|
Email:
|
loubertch@yahoo.fr |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Uterine Atony
|
|
Postpartum Hemorrhage
|
|
Intervention(s)
|
|
Drug: Carbetocin
|
|
Primary Outcome(s)
|
|
Dose of carbetocin which will prevent uterine atony in 90% of subjects
[Time Frame: 5 minutes]
|
|
Secondary Outcome(s)
|
|
Vasopressors administered
[Time Frame: 20 minutes]
|
|
Anti nausea therapy
[Time Frame: 20 minutes]
|
|
Incidence of side effects
[Time Frame: 20 minutes]
|
|
Additional uterine massage
[Time Frame: 20 minutes]
|
|
Additional uterotonic medication administered
[Time Frame: 20 minutes]
|
|
Secondary ID(s)
|
|
LoubertHMR2012/01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|