UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040663 |
|---|---|
| Receipt number | R000046416 |
| Scientific Title | Retrospective study of fetal lung function by Magnetic resonance imaging |
| Date of disclosure of the study information | 2020/06/05 |
| Last modified on | 2025/07/02 15:48:05 |
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Basic information
Public title
Retrospective study of fetal lung function by Magnetic resonance imaging
Acronym
Retrospective study of fetal lung function by Magnetic resonance imaging
Scientific Title
Retrospective study of fetal lung function by Magnetic resonance imaging
Scientific Title:Acronym
Retrospective study of fetal lung function by Magnetic resonance imaging
Region
| Japan |
Condition
Condition
fetal lung hypoplasia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prediction of fetal lung function by fetal MRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neonatal respiratory disorder
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
pregnant woman
Key exclusion criteria
A person who does not give an informed consent
Target sample size
300
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
143-0015
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 | Junya |
| Middle name | |
| Last name | Sakuma |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-0015
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
junya.sakuma@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University
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
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
| 2020 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.omori.med.toho-u.ac.jp/byoin/ethical_committee/syonin_ichiran_2019.html
Publication of results
Published
Result
URL related to results and publications
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.14833
Number of participants that the trial has enrolled
191
Results
Low o/e LLSIR might reflect the histological characteristics of hypoplastic lung structures. O/e LLSIR seems to be a useful MRI parameter for screening FPH.
Results date posted
| 2025 | Year | 07 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent fetal MRI
Participant flow
Patients who gave a written informed consent
Adverse events
none
Outcome measures
LLSIR and fetal lung hypoplasia
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 05 | Month | 03 | Day |
Other
Other related information
Retrospective data analysis by medical records
Management information
Registered date
| 2020 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046416
