Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000550000
Ethics application status
Approved
Date submitted
25/06/2010
Date registered
8/07/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficiency of carbetocin in the prevention of the postpartum haemorrhage :a clinical double-blinded randomized study .
Scientific title
Comparison of the effectiveness of carbetocin vs oxytocin in managing the third stage of labor in a group of women with risk factors for postpartum hemorrhage.
Secondary ID [1] 252060 0
nil
Universal Trial Number (UTN)
U1111-1115-5309
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postpartum haemorrhage 257597 0
Condition category
Condition code
Reproductive Health and Childbirth 257771 257771 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
carbetocin ampule x 100 mcg diluted in 10 cc of saline administered as a single intravenous bolus dose in the management of the third phase of labor.
Intervention code [1] 256688 0
Treatment: Drugs
Intervention code [2] 256769 0
Prevention
Comparator / control treatment
oxytocin ampule x 10 units diluted in 10 cc of saline administered as a single intravenous bolus in the managing of the third period of the labor followed by an intravenous administration of 60 units of oxytocin diluted in 1000 cc of saline (saline solution 0.9%) at a rate de 80 mL/h over 12 hours starting immediately after delivery of the infant.
Control group
Active

Outcomes
Primary outcome [1] 258643 0
The primary outcome is average postpartum bleeding within 24 hours of delivery in each of the groups. the volume of blood will be collected from diapers every 6 hours for 24 hours. Previously, design a linear regression which shows the volume of bleeding according to the weight of each diaper.

each of the diapers collected is weighed and get the respective volume derived from the linear regression. The sum of the four diapers provides postpartum bleeding within 24 hours.
Timepoint [1] 258643 0
first 24 hours after birth
Secondary outcome [1] 264613 0
percentage of adverse drug effects. Headache, nauseas, difficulty to breathe, abdominal pain , syncope, dizziness, changes in the arterial pressure, metallic flavor.These adverse effects are gathered across surveys realized at 12 and 24 hours after applied the intervention on the management of the third phase of labor in each group .
Timepoint [1] 264613 0
at 12 and 24 hours after administration of the intervention on the management of the third phase of labor in each group .
Secondary outcome [2] 264614 0
percentage of additional interventions to control postpartum bleeding. Use of additional doses of oxytocin, misoprotol, derived from the ergot, uterine massage, blood products, surgical intervention in order to stop bled. These interventions are gathered across surveys realized at 24 hours after applied applied the intervention on the management of the third phase of labor in each group .
Timepoint [2] 264614 0
first 24 hours after birth

Eligibility
Key inclusion criteria
1. Pregnancy over 34 weeks.
2. Hold at history a risk factor for postpartum haemorrhague as nulliparous, multiple pregnancy, hypertensive disease, induction of labor, fetal macrosomia fetus, more than 35 years, obesity, second period of prolonged labor, precipitate labor, chorioamnionitis and prolonged third period of labor.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Mental retardation.
2. Coagulation disorder.
3. Renal failure.
4. Liver failure.
5. Heart failure.
6. Heart rhythm disorders.
7. Central placenta previa total.
8. Indication of caesarean.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolling: Once the patient enters to room of childbirths and fulfills the criteria of incorporation and exclusion one invites to take part and to signing the informed consent to be included in the study.
The assignment of the treatment is carried out to the beginning of the second phase of the labor. The doctor in charge of the room of childbirths, across telephonic line, requests a code of assignment. The treatment is in sealed opaque envelopes with the respective code and his content does not allow to know which treatment is applied
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 2703 0
Colombia
State/province [1] 2703 0

Funding & Sponsors
Funding source category [1] 257155 0
Hospital
Name [1] 257155 0
clinica versalles
Country [1] 257155 0
Colombia
Primary sponsor type
Individual
Name
milton gomez
Address
avenue 64A #13a 74 apartment 303F
Santiago de Cali
Valle del cauca.
postal code of the city of Cali: 76001000
Country
Colombia
Secondary sponsor category [1] 256413 0
Commercial sector/Industry
Name [1] 256413 0
BIOTEFAR laboratory
Address [1] 256413 0
street 24 north #8 North -50 second floor
Santiago de Cali
Valle del cauca.
postal code of the city of Cali: 76001000
Country [1] 256413 0
Colombia
Other collaborator category [1] 251332 0
University
Name [1] 251332 0
Pontificia Universidad Javeriana
Address [1] 251332 0
street 18 # 118-250 Santiago de Cali
Valle del Cauca.
postal code of the city of Cali: 76001000
Country [1] 251332 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259234 0
comite de etica Clinica versalles
Ethics committee address [1] 259234 0
Avenue 5 north # 23-42
Santiago de Cali.
Valle del cauca.
postal code of the city of Cali: 76001000
Ethics committee country [1] 259234 0
Colombia
Date submitted for ethics approval [1] 259234 0
03/05/2010
Approval date [1] 259234 0
17/05/2010
Ethics approval number [1] 259234 0

Summary
Brief summary
Postpartum haemorrhage (PPH) is a major cause of morbidity and mortality in the world. The present study aims to compare the effectiveness of carbetocin and oxytocin in the prevention of bleeding that occurs within 24 hours after delivery, in a group of pregnant women with risk factors for PPH.
Trial website
nothing
Trial related presentations / publications
nothing
Public notes

Contacts
Principal investigator
Name 31306 0
Address 31306 0
Country 31306 0
Phone 31306 0
Fax 31306 0
Email 31306 0
Contact person for public queries
Name 14553 0
Milton cesar Gomez gomez
Address 14553 0
avenue 64A #13A -74 apto 303F
Santiago de Cali.
Valle del Cauca.
postal code of the city of Cali: 76001000
Country 14553 0
Colombia
Phone 14553 0
+57 315 5485450 cell phone
Fax 14553 0
+57 2 3395019 telephone
Email 14553 0
[email protected]
Contact person for scientific queries
Name 5481 0
Milton cesar Gomez gomez
Address 5481 0
avenue 64A #13A -74 apto 303F
Santiago de Cali.
Valle del Cauca.
postal code of the city of Cali: 76001000
Country 5481 0
Colombia
Phone 5481 0
+57 315 5485450 cell phone
Fax 5481 0
+57 2 3395019 telephone
Email 5481 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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