Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Alexandria Faculty of Medicine, Elazarita, Alexandria, Egypt.
post code: 03312
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
women attending for post-partum care and wound evaluation one week after elective cesarean delivery were examined by ultrasound to detect the presence of hematometra (blood inside uterine cavity). When present cases were followed up clinically and sonographically till its disappearance or till the end of puerperium.
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.