Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001641886
Ethics application status
Approved
Date submitted
27/01/2021
Date registered
30/11/2021
Date last updated
30/11/2021
Date data sharing statement initially provided
30/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Placentas of Women with Endometriosis
Scientific title
Morphological Evaluation of Placentas of Pregnant Women with Endometriosis
Secondary ID [1] 303262 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 320447 0
Pregnancy 320448 0
Condition category
Condition code
Reproductive Health and Childbirth 318339 318339 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 321899 321899 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Placentas of women with endometriosis will be morphologically evaluated after delivery The analysis will be held in accordance with the placental classification system defined by G Turowski , L N Berge, L B Helgadottir et al., 2012;33(12):1026-35. This system is clinically oriented, unifying and simple placental pathology classification defining mainly nine major diagnostic categories including normal placenta.
Clinical Diagnostic categories are listed below:
1.Placenta with normal morphology,according to gestational age
2. Placenta with chorioamnionitis
3. Placenta with villitis and intervillositis
4. Placenta with maternal circulatory disorders
(decidual vasculopathy)
5. Placenta with fetal circulatory disorders
6. Placenta with delayed villous maturation
7. Placenta with findings, suggestive of genetic aberration
8. Placenta with implantation disorders
9. Placenta with other lesions
Each clinical situation has major defining characteristics defined by the authors.
The placentas will be transported to Pathology Department in the same hospital as soon as delivered. The specimens will be fixed and stored until the histopathological examination.
Each patient will be questioned about demographic variables but also antenatal problems such as antenatal bleeding in any trimester, placenta previa, small for gestational age, diabetes mellitus etc. But also, each patient will be questioned about the diagnostic procedures held for endometriosis, the stage of endometriosis and the time to pregnancy after the operation etc. The questionnaires for each patient will be filled by the gynecologist by the interview with the patient. A ten minute questionnaire will be held for this purpose.
Intervention code [1] 319562 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326305 0
Establishment of any distortion in placental histopathology from normal in placentas of women with endometriosis.
The morphological evaluation of placentas of women with endometriosis, who delivered after 20th week of pregnancy will be held in accordance with the classification system defined by Turowski G. et al., (A new, clinically oriented, unifying and simple placental classification system, Placenta 2012 Dec;33(12):1026-35. doi: 10.1016/j.placenta.2012.10.002.).
Timepoint [1] 326305 0
within 10 days after placental removal in C-section for each patient
Secondary outcome [1] 403310 0
Determination of antenatal complications in pregnant women with endometriosis by a questionnaire which is designed for this study. The questionnaire consists of adverse perinatal outcomes such as antenatal bleeding, preeclampsia, preterm deliery etc. which have been recently correlated with endometriosis in the literature.
Timepoint [1] 403310 0
The 10 minute questionnaire will be held at the last visit before delivery

Eligibility
Key inclusion criteria
Histopathologically confirmed diagnosis of endometriosis in a pregnant woman and delivery of the fetus after 20th week of pregnancy whether viable or not.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is the first study aims to evaluate histo-pathological properties of placentas of women with endometriosis. This is why, a power analysis can not be held for determination of the study population. The authors aim to define the distorted histo-pathological properties of those placentas to guide further research in this field of research.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 23411 0
Turkey
State/province [1] 23411 0
Ankara

Funding & Sponsors
Funding source category [1] 307670 0
Self funded/Unfunded
Name [1] 307670 0
Country [1] 307670 0
Primary sponsor type
Individual
Name
Asli Yarci Gursoy
Address
Ufuk Universitesi Dr. Ridvan Ege Hastanesi
Kizilirmak, Ufuk Ünv. Cd No:1, 06510 Çankaya/Ankara
Country
Turkey
Secondary sponsor category [1] 310445 0
None
Name [1] 310445 0
Address [1] 310445 0
Country [1] 310445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307709 0
Ufuk University Faculty of Medicine
Ethics committee address [1] 307709 0
Ethics committee country [1] 307709 0
Turkey
Date submitted for ethics approval [1] 307709 0
01/07/2020
Approval date [1] 307709 0
08/07/2020
Ethics approval number [1] 307709 0
20200708/6

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

Contacts
Principal investigator
Name 108222 0
Dr Asli Yarci Gürsoy
Address 108222 0
Ufuk Üniversitesi Tip Fakültesi Dr Ridvan Ege Hastanesi
Kizilirmak, Ufuk Ünv. Cd No:1, 06510 Çankaya/Ankara
Country 108222 0
Turkey
Phone 108222 0
+903122044212
Fax 108222 0
Email 108222 0
[email protected]
Contact person for public queries
Name 108223 0
Asli YarciGürsoy
Address 108223 0
Ufuk Universitesi Dr. Ridvan Ege Hastanesi
Kizilirmak, Ufuk Ünv. Cd No:1, 06510 Çankaya/Ankara
Country 108223 0
Turkey
Phone 108223 0
+903122044212
Fax 108223 0
Email 108223 0
[email protected]
Contact person for scientific queries
Name 108224 0
Asli Yarci Gürsoy
Address 108224 0
Ufuk Universitesi Dr. Ridvan Ege Hastanesi
Kizilirmak, Ufuk Ünv. Cd No:1, 06510 Çankaya/Ankara
Country 108224 0
Turkey
Phone 108224 0
+903122044212
Fax 108224 0
Email 108224 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The individual participant data regarding histo-pathological evaluation might be shared on request.
When will data be available (start and end dates)?
The data will be complete when the targeted number of patients are included and will be available for about 1 year.
Available to whom?
On request
Available for what types of analyses?
The data will be shared on request for any research purpose (meta-analyses etc.).
How or where can data be obtained?
The data will be shared on request via e mail ([email protected]) of the primary investigator, Asli Yarci Gürsoy.


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.