UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034744 |
|---|---|
| Receipt number | R000039610 |
| Scientific Title | The establishment of the diagnostic method of fetal skeletal dysplasia using 3-dymensional computed tomography (3D-CT) and protocol making |
| Date of disclosure of the study information | 2018/11/10 |
| Last modified on | 2025/11/14 10:16:28 |
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Basic information
Public title
The establishment of the diagnostic method of fetal skeletal dysplasia using 3-dymensional computed tomography (3D-CT) and protocol making
Acronym
Diagnosis of fetal skeletal dysplasia using 3D-CT
Scientific Title
The establishment of the diagnostic method of fetal skeletal dysplasia using 3-dymensional computed tomography (3D-CT) and protocol making
Scientific Title:Acronym
Diagnosis of fetal skeletal dysplasia using 3D-CT
Region
| Japan |
Condition
Condition
fetal skeletal dysplasia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine 3D-CT imaging method to establish an accurate diagnosis of fetal skeletal dysplasia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fetal femur length, shape of long bones, Ossification of bones
Key secondary outcomes
evaluateon of the postnatal whole bones
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
| Not applicable |
Gender
Female
Key inclusion criteria
the patient suspected fetal skeletal dysplasia using fetal ultrasound examination
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Miyoko |
| Middle name | |
| Last name | Waratani |
Organization
Kyoto Prefectural University of Medicine
Division name
Obstetrics and Gynecology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5560
mwara@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Miyoko |
| Middle name | |
| Last name | Waratani |
Organization
Kyoto Prefectural University of Medicine
Division name
Obstetrics and Gynecology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5560
Homepage URL
mwara@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku, Kyoto-shi, Kyoto
Tel
075-251-5560
rinri@koto.kpu-m.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
京都府立医科大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
We investigated the prenatal diagnosis and postnatal definitive diagnosis for cases of fetal skeletal dysplasia to examine the efficacy of 3D-CT for prenatal diagnosis of fetal skeletal dysplasia.
Management information
Registered date
| 2018 | Year | 11 | Month | 01 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039610
