Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
ACTRN12613000160730
Ethics application status
Approved
Date submitted
5/02/2013
Date registered
11/02/2013
Date last updated
11/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of cesarean scar thickness during elective repeat cesarean delivery.
Scientific title
Evaluation of cesarean scar thickness during elective repeat cesarean delivery
Secondary ID [1] 281895 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cesarean delivery 288295 0
Condition category
Condition code
Reproductive Health and Childbirth 288638 288638 0 0
Childbirth and postnatal care
Surgery 288665 288665 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
during elective cesarean in women with previous cesarean scar thickness is crudely categorized into 3 groups; thin, medium, and thick. Scar thickness is correlated to number and circumstances of previous cesarean sections.
Intervention code [1] 286459 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288795 0
Cesarean scar thickness is subjectively assessed into thin and transparent (similar to peritoneum), medium fibrous ( similar to sheath), and thick muscular ( similar to adjacent myometrium)
Timepoint [1] 288795 0
intra-operative
Secondary outcome [1] 301007 0
nil
Timepoint [1] 301007 0
nil

Eligibility
Key inclusion criteria
previous 1-4 cesarean delivery, undergoing repeat cesarean delivery, full-term pregnancy, singleton fetus, cephalic presentation.
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Multiple pregnancy, abnormal presentation, placenta previa.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
1/09/2012
Actual
1/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4839 0
Egypt
State/province [1] 4839 0

Funding & Sponsors
Funding source category [1] 286682 0
Self funded/Unfunded
Name [1] 286682 0
Mervat Sheikh Elarab Elsedeek Omran
Country [1] 286682 0
Egypt
Primary sponsor type
Individual
Name
Mervat Sheikh Elarab Elsedeek Omran
Address
649 Elhorreya street, Janaklis, Alexandria, Egypt.
postcode:03312
Country
Egypt
Secondary sponsor category [1] 285456 0
None
Name [1] 285456 0
None
Address [1] 285456 0
Country [1] 285456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288750 0
Alexandria Faculty of Medicine ethical comittee
Ethics committee address [1] 288750 0
Alexandria Faculty of Medicine, Azarita, Alexandria, Egypt.
postcode:03312
Ethics committee country [1] 288750 0
Egypt
Date submitted for ethics approval [1] 288750 0
Approval date [1] 288750 0
01/10/2010
Ethics approval number [1] 288750 0

Summary
Brief summary
Scar of previous cesarean is assessed intra operatively during repeat CD and thickness is correlated to number and circumstances of previous CD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37374 0
Prof Mervat Sheikh Elarab Elsedeek Omran
Address 37374 0
649 Elhorreya street, Janaklis, Alexandria, Egypt.
postcode:03312
Country 37374 0
Egypt
Phone 37374 0
+203 5759915
Fax 37374 0
Email 37374 0
mervatsheikhelarab@yahoo.com
Contact person for public queries
Name 37375 0
Mervat Sheikh Elarab Elsedeek Omran
Address 37375 0
649 Elhorreya street, Janaklis, Alexandria, Egypt.
postcode:03312
Country 37375 0
Egypt
Phone 37375 0
+203 5759915
Fax 37375 0
Email 37375 0
mervatsheikhelarab@yahoo.com
Contact person for scientific queries
Name 37376 0
Mervat Sheikh Elarab Elsedeek Omran
Address 37376 0
649 Elhorreya street, Janaklis, Alexandria, Egypt.
postcode:03312
Country 37376 0
Egypt
Phone 37376 0
+203 5759915
Fax 37376 0
Email 37376 0
mervatsheikhelarab@yahoo.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.