Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000117617
Ethics application status
Approved
Date submitted
21/01/2014
Date registered
30/01/2014
Date last updated
30/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Carbetocin versus syntometrine for prevention of postpartum hemorrhage after cesarean section
Scientific title
Carbetocin versus syntometrine for prevention of postpartum hemorrhage after cesarean section
Secondary ID [1] 283954 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postpartum hemorrhage 290977 0
Condition category
Condition code
Reproductive Health and Childbirth 291320 291320 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
single 100 microgram IV dose of carbetocin (Pabal) after fetal extraction and before placental removal
Intervention code [1] 288642 0
Prevention
Intervention code [2] 288660 0
Treatment: Drugs
Comparator / control treatment
single dose IV combination of 5 IU oxytocin and 0.2 mg ergometrine after fetal extraction and before placental removal
Control group
Active

Outcomes
Primary outcome [1] 291312 0
occurrence of postpartum hemorrhage (defined as a blood loss of greater than 1000 ml of blood following caesarean section)
Timepoint [1] 291312 0
24 hours
Secondary outcome [1] 306493 0
need of additional oxytocic
Timepoint [1] 306493 0
24 hours
Secondary outcome [2] 306494 0
side effects of drugs e.g. nausea, vomiting,metallic taste, shivering, flushing, headache, dizziness, dyspnea, and itching assessed by number of participants experienced that.
Timepoint [2] 306494 0
24 hours

Eligibility
Key inclusion criteria
37 – 40 weeks of gestational age
noncomplicated pregnancy.
Cesarean sections are a mixture of planned and emergency interventions under regional anaesthesia
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
placenta previa
coagulopathy
preeclamptic
known sensitivity to oxytocin or methergine

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
1/06/2011
Date of last participant enrolment
Anticipated
30/05/2013
Actual
30/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment outside Australia
Country [1] 5763 0
Egypt
State/province [1] 5763 0
Cairo

Funding & Sponsors
Funding source category [1] 288587 0
Self funded/Unfunded
Name [1] 288587 0
Ahmed Maged
Country [1] 288587 0
Egypt
Primary sponsor type
Individual
Name
Ahmed Maged
Address
Kasr Aini medical school . 135 king Faisal street, Haram Giza Egypt. postal code 12151
Country
Egypt
Secondary sponsor category [1] 287295 0
Individual
Name [1] 287295 0
Ali abdelhafiz
Address [1] 287295 0
Kasr Aini medical school .1 Kasr Aini street Manial Cairo Egypt Postal code 12245
Country [1] 287295 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290450 0
Kasr Aini local ethical committe
Ethics committee address [1] 290450 0
1 Kasr Aini street Manial Cairo Egypt Postal code 12245
Ethics committee country [1] 290450 0
Egypt
Date submitted for ethics approval [1] 290450 0
Approval date [1] 290450 0
20/04/2011
Ethics approval number [1] 290450 0

Summary
Brief summary
A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 microgram IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after Cesarean section
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45758 0
Prof Ahmed Maged
Address 45758 0
Kasr Aini medical school. 135 King faisal street , Haram , Giza Egypt. Postal code 12151
Country 45758 0
Egypt
Phone 45758 0
+2001005227404
Fax 45758 0
Email 45758 0
[email protected]
Contact person for public queries
Name 45759 0
Prof Ahmed Maged
Address 45759 0
Kasr Aini medical school.135 King faisal street , Haram , Giza Egypt. Postal code 12151
Country 45759 0
Egypt
Phone 45759 0
+2001005227404
Fax 45759 0
Email 45759 0
[email protected]
Contact person for scientific queries
Name 45760 0
Prof Ahmed Maged
Address 45760 0
Kasr Aini medical school. 135 King faisal street , Haram , Giza Egypt. Postal code 12151
Country 45760 0
Egypt
Phone 45760 0
+2001005227404
Fax 45760 0
Email 45760 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseConcerns about Data Integrity of 22 Randomized Controlled Trials in Women's Health.2023https://dx.doi.org/10.1055/s-0041-1727280
N.B. These documents automatically identified may not have been verified by the study sponsor.