UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051671 |
|---|---|
| Receipt number | R000058968 |
| Scientific Title | Study of Fetal Thrombotic Vasculopathy Associated with Placental and Umbilical Cord Abnormalities |
| Date of disclosure of the study information | 2023/08/04 |
| Last modified on | 2023/07/21 01:07:03 |
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Basic information
Public title
Study of Fetal Thrombotic Vasculopathy Associated with Placental and Umbilical Cord Abnormalities
Acronym
Study of Fetal Thrombotic Vasculopathy
Scientific Title
Study of Fetal Thrombotic Vasculopathy Associated with Placental and Umbilical Cord Abnormalities
Scientific Title:Acronym
Study of Fetal Thrombotic Vasculopathy
Region
| Japan |
Condition
Condition
Fetal Thrombotic Vasculopathy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish prenatal ultrasound diagnostic methods for fetal thrombotic vasculopathy.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirm the consistency of ultrasound findings of the placenta during pregnancy from cases in which cord blood at birth suggests fetal thrombotic vasculopathy and placental pathology suggests fetal thrombotic vasculopathy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
One medical procedure ultrasound time beyond normal medical care
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
Male and Female
Key inclusion criteria
Pregnant woman with a singleton pregnancy scheduled for delivery at St. Marianna University Hospital.
Key exclusion criteria
Cases of excessive time taken during umbilical cord blood collection
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Hasegawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
dr.hasejun@outlook.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Saji |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
Homepage URL
seaspoon32@gmail.com
Sponsor or person
Institute
St. Marianna University School of Medicine
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
Nichibo Ogya Donation Fund (Public Interest Incorporated Foundation)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
0449778111
seaspoon32@gmail.com
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
| 2023 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058968
