UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033161 |
|---|---|
| Receipt number | R000037820 |
| Scientific Title | High-precision pathological analysis of funisitis |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2021/06/04 13:54:43 |
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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 | Obstetrics 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
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
yuha@gifu-u.ac.jp
Sponsor or person
Institute
Department of Tumor Pathology, Gifu University Graduate School of Medicine
Institute
Department
Personal name
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
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
https://doi.org/10.1016/j.placenta.2021.03.008
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.placenta.2021.03.008
Number of participants that the trial has enrolled
261
Results
Analysis of results based on CD15-assisted scoring system
revealed that severe umbilical phlebitis (score 3) was signi
ficantly associated with maternal inflammatory response a
nd that severe umbilical arteriophlebitis (score 4) was corr
elated with low umbilical arterial blood pH, a feature linked
to fetal mortality and morbidity.
Results date posted
| 2021 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
Obstetric cases followed between January 2013 and March
2018 were retrieved from the pathology division of Gifu Un
iversity Hospital.
Participant flow
Not applicable because of observational study
Adverse events
Not applicable because of observational study
Outcome measures
Relationship between CD15-assisted umbilical cord inflam
mation score and clinicopathological findings
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037820
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
