Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001660471
Ethics application status
Approved
Date submitted
1/10/2016
Date registered
1/12/2016
Date last updated
1/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
management of abnormal lower uterine segment after fetal delivery in cesarean section
Scientific title
multiple lower uterine plication sutures with both uterine arteries included at each suture in management of abnormal lower uterine segment with placenta previa ,accreta and thinned out segement
Secondary ID [1] 290250 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum hemorrhage 300464 0
placenta accreta 301007 0
placenta previa 301008 0
Condition category
Condition code
Reproductive Health and Childbirth 300320 300320 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multiple lower uterine plication sutures with bilateral uterine artery ligation in the same suture starting low down and going up to the uterine incision.
obstetrician with minimum 5 years’ experience will do the surgery after fetal delivery..
The approximate duration of the procedure one hour ..
Intervention code [1] 296038 0
Treatment: Surgery
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299787 0
Control of hemorrhage from lower uterine segment by reviewing the medical records
Timepoint [1] 299787 0
During surgery
Secondary outcome [1] 328114 0
Duration of surgery by review of medical records
Timepoint [1] 328114 0
During surgery

Eligibility
Key inclusion criteria
Participants will be included if they have one of the following:
1. ballooned and oozing lower uterine segment from placenta previa
2. placenta accreta
3. thinned out lower segment
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.placenta percreta
2.hemodynamically unstable

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 8286 0
Egypt
State/province [1] 8286 0
ALEXANDRIA

Funding & Sponsors
Funding source category [1] 294619 0
University
Name [1] 294619 0
alexandria university
Country [1] 294619 0
Egypt
Primary sponsor type
Hospital
Name
shatby maternity university hospital
Address
portsaied street beside bibliotheca alexandrina ,alexandria ,egypt 22055
Country
Egypt
Secondary sponsor category [1] 293481 0
University
Name [1] 293481 0
alexandria university
Address [1] 293481 0
portsaied street beside bibliotheca alexandrina ,alexandria ,egypt 20225
Country [1] 293481 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296060 0
alexandria university ethics committee
Ethics committee address [1] 296060 0
portsaied street beside bibliotheca alexandrina ,alexandria ,egypt 22055
Ethics committee country [1] 296060 0
Egypt
Date submitted for ethics approval [1] 296060 0
07/09/2016
Approval date [1] 296060 0
28/09/2016
Ethics approval number [1] 296060 0

Summary
Brief summary
This study will be conducted in shatby hospital over 30 patients,
3 groups will be included.
One with thinned out lower segment .
One with placenta previa.
One with placenta accreta
All will undergo multiple transverse compression suture with bilateral uterine artery included in suture.
The main outcome is success of procedure in arrest in bleeding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69398 0
Dr AHMED SAMY
Address 69398 0
alexandria univeristy ,portsaied street beside bibliotheca alexandrina ,alexandria,egypt 22055
Country 69398 0
Egypt
Phone 69398 0
+201228254247
Fax 69398 0
Email 69398 0
[email protected]
Contact person for public queries
Name 69399 0
Dr AHMED SAMY
Address 69399 0
alexandria univeristy ,portsaied street beside bibliotheca alexandrina ,alexandria,egypt 20225
Country 69399 0
Egypt
Phone 69399 0
+201228254247
Fax 69399 0
Email 69399 0
[email protected]
Contact person for scientific queries
Name 69400 0
Dr AHMED SAMY
Address 69400 0
alexandria univeristy ,portsaied street beside bibliotheca alexandrina ,alexandria,egypt 20255
Country 69400 0
Egypt
Phone 69400 0
+201228254247
Fax 69400 0
Email 69400 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.