UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037702 |
|---|---|
| Receipt number | R000042999 |
| Scientific Title | Study of the pathophysiology of fetal circulatory changes in monochorionic twin pregnancies. |
| Date of disclosure of the study information | 2019/08/16 |
| Last modified on | 2022/08/18 10:34:19 |
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Basic information
Public title
Study of the pathophysiology of fetal circulatory changes in monochorionic twin pregnancies.
Acronym
Study of fetal circulatory changes in monochorionic twin pregnancies.
Scientific Title
Study of the pathophysiology of fetal circulatory changes in monochorionic twin pregnancies.
Scientific Title:Acronym
Study of fetal circulatory changes in monochorionic twin pregnancies.
Region
| Japan |
Condition
Condition
twin-to-twin transfusion syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the mechanism of fetal circulatory failure in compromised monochorionic twin pregnancies.
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biomarker in amniotic fluid and umbilical cord blood. Vascular substances in placental tissue. Neonatal condition.
Relations between these parameters and ultrasound indices.
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
monochorionic twin pregnancies
Key exclusion criteria
Someone in socially vulnerable position
Target sample size
100
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
1438541
Address
6-11-1 Omorinishi, Ota-ku, 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
1438541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
masahiko.nakata@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
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
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541
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
| 2019 | Year | 08 | Month | 16 | 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
60
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
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 08 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042999
