Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001202257p
Ethics application status
Submitted, not yet approved
Date submitted
3/07/2018
Date registered
18/07/2018
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
How much is the Scar Defect prevalent after the first Cesarean section detected by normal saline injection intrauterine and what are factors contributing its occurrence.
Scientific title
Prevalence of Scar Defect after first Cesarean section Detected by Saline Sonohystrography and Factors Affecting.
Secondary ID [1] 295137 0
none
Universal Trial Number (UTN)
U1111-1215-3987
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cesarean section 308672 0
Condition category
Condition code
Reproductive Health and Childbirth 307603 307603 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
Women undergone one cesarean section done in each hospital and eligible for study will be given instruction to come 6 months later for 2D transvaginal ultrasound and saline sonohystrography.
Intervention code [1] 301729 0
Diagnosis / Prognosis
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306576 0
Indication of section: emergency (at what cervical dilation /cm) or elective,induced or spontaneous onset. these data will be collected from study-specific sheet
Timepoint [1] 306576 0
once at time of enrollment
Primary outcome [2] 306577 0
Surgeon doing cesarean section (resident, specialist, consultant). recorded in study-specific sheet
Timepoint [2] 306577 0
once at time of enrollment
Primary outcome [3] 306578 0
Repair of uterus in one or two layers reported in operative details in hospital records.
Timepoint [3] 306578 0
once at 6 months after first cesarean section
Secondary outcome [1] 348934 0
Presence of intraoperative complications (hematoma, extension of angle or lower segment),collected from study-specific sheet
Timepoint [1] 348934 0
once ,reported immediately after cesarean section and recorded in study-specific sheet
Secondary outcome [2] 348935 0
Suture material used, reported immediately after cesarean section and reported in study-specific sheet
Timepoint [2] 348935 0
once, reported immediately after cesarean section and in study-specific sheet
Secondary outcome [3] 348936 0
Peritonium closed or not, reported immediately after cesarean section and in study-specific sheet
Timepoint [3] 348936 0
once ,reported immediately after cesarean section and in study-specific sheet
Secondary outcome [4] 348937 0
Presence wound infection or puerperal sepsis,reported in study-specific sheet
Timepoint [4] 348937 0
once, reported within a week after cesarean section and in study-specific sheet

Eligibility
Key inclusion criteria
Pregnant women indicated for CS for first time ,with full term singleton fetus
Minimum age
20 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1-Preterm CS, multiple pregnancy, women used intrauterine device as contraceptive method inserted duringCS.
2-Women with any structural uterine abnormality,fibroid or with pelvic infection at time of saline sonohystrography.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data were analyzed using Statistical Program for Social Science (SPSS) version 25.0. Quantitative data will be expressed as mean ± standard deviation (SD), Median and I-Q range for non-parametric data and compared using Student t test or Mann–Whitney U test, as appropriate. Qualitative data will be expressed as frequency and percentage and compared via Chi square test or Fisher exact test, as appropriate. Pearson or Spearman correlation for categorical or continuous data. Regression analysis.P < 0.05 was considered to be statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/12/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 10607 0
Egypt
State/province [1] 10607 0
cairo

Funding & Sponsors
Funding source category [1] 299729 0
Hospital
Name [1] 299729 0
Alzhraa university hospital
Country [1] 299729 0
Egypt
Primary sponsor type
Individual
Name
Nahed allam
Address
Alazhar university ,almokhayam eldaem street,elhy elsabea,nasr city
PO box 11751
Country
Egypt
Secondary sponsor category [1] 299064 0
Hospital
Name [1] 299064 0
Alzhraa university hospital
Address [1] 299064 0
Almostashfa alyouany street,abassia,cairo
PO box 11751
Country [1] 299064 0
Egypt

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300619 0
Alazhar ethical commitee
Ethics committee address [1] 300619 0
Ethics committee country [1] 300619 0
Egypt
Date submitted for ethics approval [1] 300619 0
27/05/2018
Approval date [1] 300619 0
Ethics approval number [1] 300619 0

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

Contacts
Principal investigator
Name 84234 0
Dr Nahed Allam
Address 84234 0
Alazhar university hospital ,almostashfa elyounany street ,abassia,cairo
PO 11751
Country 84234 0
Egypt
Phone 84234 0
+2001121116136
Fax 84234 0
Email 84234 0
nahedallam16@gmail.com
Contact person for public queries
Name 84235 0
Nahed Allam
Address 84235 0
Alzhraa university ,almostashfa elyounany street ,abassia,cairo
PO 11751
Country 84235 0
Egypt
Phone 84235 0
+2001121116136
Fax 84235 0
Email 84235 0
nahedallam16@gmail.com
Contact person for scientific queries
Name 84236 0
Nahed Allam
Address 84236 0
Alzhraa university hospital,almostashfa elyounany street ,abassia,cairo
PO 11751
Country 84236 0
Egypt
Phone 84236 0
+2001121116136
Fax 84236 0
Email 84236 0
nahedallam16@gmail.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.