Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001018000
Ethics application status
Approved
Date submitted
18/11/2010
Date registered
22/11/2010
Date last updated
22/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Misoprostol versus Oxytocin as prophylaxes against intraoperative and postoperative bleeding in cesarean section
Scientific title
Misoprostol versus Oxytocin as prophylaxes against intraoperative and postoperative bleeding in cesarean section
Secondary ID [1] 253120 0
no secondary Id
Universal Trial Number (UTN)
U1111-1118-2108
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bleeding in cesarean section 258682 0
Condition category
Condition code
Reproductive Health and Childbirth 258828 258828 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
600 microgram misoprostol (3 tablets) administrated rectally, right after induction of anesthesia.
Intervention code [1] 257641 0
Treatment: Drugs
Intervention code [2] 257646 0
Prevention
Comparator / control treatment
10 ml oxytocin infused with 500 cc ringer solution right after clamping of the cord
Control group
Active

Outcomes
Primary outcome [1] 259690 0
Intraoperative blood loss during Elective lower segment cesarean sections
Timepoint [1] 259690 0
Number and weight differences of towels used intraoperatively
Secondary outcome [1] 266387 0
change in Hemoglobin levels pre and post operative
Timepoint [1] 266387 0
Measuring blood hemoglobin pre and post operative

Eligibility
Key inclusion criteria
patients admitted for elective lower segment cesarean section
Minimum age
15 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
patients with risk factors for postpartum hemorrhage, emergency lower segment cesarean section, or known hypersensitivity to prostaglandins.

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)
Sealed opaque envelops (containers)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Randomization using a randomization table created by a computer software
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
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment outside Australia
Country [1] 3055 0
Egypt
State/province [1] 3055 0
Cairo

Funding & Sponsors
Funding source category [1] 258096 0
Self funded/Unfunded
Name [1] 258096 0
Amany Sadek
Country [1] 258096 0
Egypt
Primary sponsor type
University
Name
Ain Shams University
Address
Ain Shams university Maternity Hospital, el demerdash Hospitals, El Abassia, Cairo, Egypt.
Country
Egypt
Secondary sponsor category [1] 257276 0
None
Name [1] 257276 0
Address [1] 257276 0
Country [1] 257276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260090 0
Ain Shams Maternity Hospital Ethics committee
Ethics committee address [1] 260090 0
Ain Shams Maternity Hospital, Eldemerdash univeristy Hospital, El Abassia, Cairo, Egypt.
Ethics committee country [1] 260090 0
Egypt
Date submitted for ethics approval [1] 260090 0
Approval date [1] 260090 0
13/10/2010
Ethics approval number [1] 260090 0

Summary
Brief summary
To compare the efficacy of rectally administrated Misoprostol vs. intravenous Oxytocin infusion during and after cesarean sections to control intraoperative and postoperative bleeding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31933 0
Address 31933 0
Country 31933 0
Phone 31933 0
Fax 31933 0
Email 31933 0
Contact person for public queries
Name 15180 0
Amany Sadek
Address 15180 0
3/A, A.O.I. buildings, Makram Ebad St., Nasr city, Cairo, Egypt.
Country 15180 0
Egypt
Phone 15180 0
020 10 65 63 603
Fax 15180 0
Email 15180 0
amanitoo@hotmail.com
Contact person for scientific queries
Name 6108 0
Amany Sadek
Address 6108 0
3/A, A.O.I. buildings, Makram Ebad St., Nasr city, Cairo, Egypt.
Country 6108 0
Egypt
Phone 6108 0
020 10 65 63 603
Fax 6108 0
Email 6108 0
amanitoo@hotmail.com

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
No additional documents have been identified.