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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033161
Receipt No. R000037820
Scientific Title High-precision pathological analysis of funisitis
Date of disclosure of the study information 2018/07/01
Last modified on 2019/12/28

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Basic information
Public title High-precision pathological analysis of funisitis
Acronym High-precision pathological analysis of funisitis
Scientific Title High-precision pathological analysis of funisitis
Scientific Title:Acronym High-precision pathological analysis of funisitis
Region
Japan

Condition
Condition Complicated pregnancy, Perinatal complications
Classification by specialty
Medicine in general Obsterics and gynecology Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the high-precision analytical methods of funisitis, using by immunohistochemistry and/or special staining.
Basic objectives2 Others
Basic objectives -Others To clarify the relationship between the funisitis and perinatal complications.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Reproducibility of funisitis staging
Key secondary outcomes Relationship between the funisitis and perinatal abnormalities

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Women whose umbilical cord was submitted to the pathological division of Gifu University Hospital from April 1, 2005 to December 1, 2018.
Key exclusion criteria Insufficient material for histological diagnosis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yuichiro
Middle name
Last name HATANO
Organization Gifu University Graduate School of Medicine
Division name Department of Tumor Pathology
Zip code 501-1194
Address 1-1 Yanagido, Gifu, Gifu
TEL 0582306225
Email yuha@gifu-u.ac.jp

Public contact
Name of contact person
1st name Yuichiro
Middle name
Last name HATANO
Organization Gifu University Graduate School of Medicine
Division name Department of Tumor Pathology
Zip code 501-1194
Address 1-1 Yanagido, Gifu, Gifu
TEL 0582306225
Homepage URL
Email yuha@gifu-u.ac.jp

Sponsor
Institute Department of Tumor Pathology, Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization independent Ethics Committee, Gifu University Graduate School of Medicine
Address 1-1 Yanagido, Gifu, Gifu
Tel 0582306059
Email rinri@gifu-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 282
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 06 Month 06 Day
Date of IRB
2018 Year 06 Month 06 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information Histological stage of funisitis analyzed with routine and non-routine pathological methods, histological grading of chorioamnionitis.
Clinical data, including maternal age, gestational age, the presence or absence of the perinatal abnormality and/or complications and medical history.

Management information
Registered date
2018 Year 06 Month 27 Day
Last modified on
2019 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037820

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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