Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000435189
Ethics application status
Approved
Date submitted
21/02/2019
Date registered
18/03/2019
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of uterine scar after cesarean delivery.
Scientific title
Assesment of Cesarean section scar during pregnancy: a prospective cohort study.
Secondary ID [1] 297308 0
None.
Universal Trial Number (UTN)
Trial acronym
CASUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 311409 0
Uterine scar 311410 0
vaginal birth after cesarean section 311411 0
uterine rupture 311412 0
Condition category
Condition code
Reproductive Health and Childbirth 310037 310037 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ultrasound evaluation of uterine scar at first trimester, second trimester and third trimester. Participant attends 10-15 minutes for evaluation of uterine scar each trimester of pregnancy.
Intervention code [1] 313560 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318938 0

Thickness of uterine scar. as assesed by transvaginal ultrasound.
Timepoint [1] 318938 0
Uterine scar thickness evaluated with transvaginal ultrasound at the time of measuring: at 11-14 weeks, at 18-20 weeks, at 34-36 weeks.
Secondary outcome [1] 366469 0
Uterine rupture during delivery, will be assessed from hospital records.
Timepoint [1] 366469 0
4-5 weeks after evaluating cesarean scar at 34-36 weeks.

Eligibility
Key inclusion criteria
Pregnant women with uterine scar after cesarean section
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple pregnancy,

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 21251 0
Lithuania
State/province [1] 21251 0
Kaunas

Funding & Sponsors
Funding source category [1] 301871 0
University
Name [1] 301871 0
Lithuanian University of Health Sciences
Country [1] 301871 0
Lithuania
Primary sponsor type
University
Name
Lithuanian University of Health Sciences
Address
Mickeviciaus g. 9, 44307 Kaunas
Country
Lithuania
Secondary sponsor category [1] 301621 0
None
Name [1] 301621 0
Address [1] 301621 0
Country [1] 301621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302563 0
Kaunas regional Bioetical committee
Ethics committee address [1] 302563 0
Mickeviciaus g. 9, Kaunas
Ethics committee country [1] 302563 0
Lithuania
Date submitted for ethics approval [1] 302563 0
09/11/2018
Approval date [1] 302563 0
10/12/2018
Ethics approval number [1] 302563 0
BE-2-85

Summary
Brief summary
Assesment of uterine scar after cesarean section: a prospective cohort study.
The aim of the study - to asses and to describe changes in Cesarean section scars longitudinally during all pegnancy. To relate initial scar measurements, risk factors and obstetrics variables to subsequent changes in scar and to pregnancy outcome.
I will use transvaginal and transabdominal sonography to examine uterine scar of pregnant women at 11-13, 18-20, 32-35 weeks of gestation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90666 0
Prof Ruta Jolanta Nadisauskiene
Address 90666 0
The Hospital of Lithuanian University of Health Sciences, Eiveniu str 2,LT-50161, Kaunas
Country 90666 0
Lithuania
Phone 90666 0
+370 37 327132
Fax 90666 0
Email 90666 0
[email protected]
Contact person for public queries
Name 90667 0
Prof Ruta Jolanta Nadisauskiene
Address 90667 0
The Hospital of Lithuanian University of Health Sciences, Eiveniu str 2,LT-50161, Kaunas
Country 90667 0
Lithuania
Phone 90667 0
+370 37 327132
Fax 90667 0
Email 90667 0
[email protected]
Contact person for scientific queries
Name 90668 0
Mrs Egle Savukyne
Address 90668 0
The Hospital of Lithuanian University of Health Sciences, Eiveniu str 2,LT-50161, Kaunas
Country 90668 0
Lithuania
Phone 90668 0
+37068515584
Fax 90668 0
Email 90668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The individual participant data will not be available becouse of state law.


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.