UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054878 |
|---|---|
| Receipt number | R000062701 |
| Scientific Title | Proteome analysis of amniotic fluid in monochorionic twins pregnancies to elucidate the fetal circulatory failure. |
| Date of disclosure of the study information | 2024/07/04 |
| Last modified on | 2024/07/04 10:43:23 |
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Basic information
Public title
Proteome analysis of amniotic fluid in monochorionic twins pregnancies to elucidate the fetal circulatory failure.
Acronym
Proteome analysis of amniotic fluid in monochorionic twin pregnancies
Scientific Title
Proteome analysis of amniotic fluid in monochorionic twins pregnancies to elucidate the fetal circulatory failure.
Scientific Title:Acronym
Proteome analysis of amniotic fluid in monochorionic twin pregnancies
Region
| Japan |
Condition
Condition
Twin-to-twin transfusion pregnancies
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyze the characteristics of proteome in amniotic fluid in complicated monochorionic twin pregnancies, and to elucidate the pathogenesis of twin-to-twin transfusion syndrome.
Basic objectives2
Others
Basic objectives -Others
Proteome analysis of amniotic fluid in recipient twin of twin-to-twin transfusion syndrome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proteome analysis of amniotic fluid
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Either monochorionic pregnancies undergo fetoscopic laser surgery or singleton pregnancies undergo amniocentesis
Key exclusion criteria
age less than 20 years old
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakata |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-8540
Address
6-11-1 Omorinishi, Ota, Tokyo
TEL
03-3762-4151
masahiko.nakata@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakata |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-8540
Address
6-11-1 Omorinishi, Ota, Tokyo
TEL
03-3762-4151
Homepage URL
masahiko.nakata@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Omori Medical Center The Institutional Ethics Committee
Address
6-11-1 Omorinishi, Ota, Tokyo
Tel
03-3762-4151
omori.rinri@ext.toho-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
| 2024 | Year | 07 | Month | 04 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2024 | Year | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062701
