Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001107718
Ethics application status
Approved
Date submitted
25/09/2013
Date registered
3/10/2013
Date last updated
3/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sonographically detected blood inside uterine cavity after cesarean birth: prevalence and clinical correlation.
Scientific title
Transabdominal sonography to detect hematometra in puerperal women attending one week after cesarean birth
Secondary ID [1] 283310 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
puerperium 290192 0
hematometra 290212 0
Condition category
Condition code
Reproductive Health and Childbirth 290580 290580 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
abdominal ultrasonography to see blood in uterine cavity one week after cesarean delivery and on weekly follow up thereafter till the end of puerperium i.e. 6 weeks after delivery.
Intervention code [1] 288028 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290599 0
disappearance of blood from uterine cavity by trans-abdominal ultrasonography
Timepoint [1] 290599 0
6 weeks after delivery
Secondary outcome [1] 304875 0
nil
Timepoint [1] 304875 0
nil

Eligibility
Key inclusion criteria
women after cesarean birth
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
excess post-partum blood loss

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
4/06/2011
Date of last participant enrolment
Anticipated
1/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5445 0
Egypt
State/province [1] 5445 0

Funding & Sponsors
Funding source category [1] 288041 0
Self funded/Unfunded
Name [1] 288041 0
Country [1] 288041 0
Primary sponsor type
Individual
Name
Mervat sheikhelarab Elsedeek Omran. Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address
649 Elhoreya road, Janaklis, Alexandria, Egypt.
post code: 03312
Country
Egypt
Secondary sponsor category [1] 286764 0
None
Name [1] 286764 0
Address [1] 286764 0
Country [1] 286764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289966 0
Alexandria Faculty of Medicine institutional review board
Ethics committee address [1] 289966 0
Ethics committee country [1] 289966 0
Egypt
Date submitted for ethics approval [1] 289966 0
01/03/2011
Approval date [1] 289966 0
16/04/2011
Ethics approval number [1] 289966 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43302 0
Prof Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address 43302 0
649 Elhoreya road, Janaklis, Alexandria.
post code: 03312
Country 43302 0
Egypt
Phone 43302 0
+203 5759915
Fax 43302 0
Email 43302 0
[email protected]
Contact person for public queries
Name 43303 0
Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address 43303 0
649 Elhoreya road, Janaklis, Alexandria.
post code: 03312
Country 43303 0
Egypt
Phone 43303 0
+203 5759915
Fax 43303 0
Email 43303 0
[email protected]
Contact person for scientific queries
Name 43304 0
Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address 43304 0
649 Elhoreya road, Janaklis, Alexandria.
post code: 03312
Country 43304 0
Egypt
Phone 43304 0
+203 5759915
Fax 43304 0
Email 43304 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
No additional documents have been identified.