UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012479 |
|---|---|
| Receipt number | R000014511 |
| Scientific Title | Survey of fetal pleural effusion in japan |
| Date of disclosure of the study information | 2013/12/04 |
| Last modified on | 2023/06/11 09:57:22 |
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Basic information
Public title
Survey of fetal pleural effusion in japan
Acronym
Fetal pleural effusion survey
Scientific Title
Survey of fetal pleural effusion in japan
Scientific Title:Acronym
Fetal pleural effusion survey
Region
| Japan |
Condition
Condition
Fetal pleural effusion
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the actual situation about the case of fetal pleural effusion in Japan.
Basic objectives2
Others
Basic objectives -Others
clinical survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survival rate
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
| 18 | weeks-old | <= |
Age-upper limit
| 34 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
Primaly fetal plueral effusion
Secondary fetal plueral effusion with Down syndrome and bronchoplumonary sequestration
Key exclusion criteria
fetal demise before 22 weeks
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | HARUHIKO |
| Middle name | |
| Last name | SAGO |
Organization
National Center for Child Health and Development
Division name
Center for Maternal-Fetal-Neonatal and Reproductive Medicine
Zip code
1578535
Address
2-10-1 Okura, Setagaya-ku, Tokyo 157-8535 Japan
TEL
03-3416-0181
sagou-h@ncchd.go.jp
Public contact
Name of contact person
| 1st name | SEIJI |
| Middle name | |
| Last name | WADA |
Organization
National Center for Child Health and Development
Division name
Center for Maternal-Fetal-Neonatal and Reproductive Medicine, Division of Fetal Medicine
Zip code
1578535
Address
2-10-1 Okura, Setagaya-ku, Tokyo 157-8535 Japan
TEL
03-3416-0181
Homepage URL
http://www.ncchd.go.jp/center/information/epidemiology/603.pdf
wada-s@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Haruhiko Sago
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo 157-8535
Tel
034160181
wada-s@ncchd.go.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
| 2013 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
https://obgyn.onlinelibrary.wiley.com/doi/full/10.1002/pd.4989
Publication of results
Published
Result
URL related to results and publications
https://obgyn.onlinelibrary.wiley.com/doi/full/10.1002/pd.4989
Number of participants that the trial has enrolled
287
Results
Among the 287 cases of primary FHT, the survival rates for those with and without hydrops were 58.0% and 97.8%, respectively. The survival rates in the no-therapy, thoracocentesis, and thoracoamniotic shunting (TAS) groups in the hydropic cases and the non-hydropic cases were 59.7%, 51.5%, and 63.3% and 98.1%, 96.3%, and 100% , respectively. The crude relative risk for death was early fetuses gestational age of fetal diagnosis, presence of both skin edema and ascites adn bilateral pleural effusion.
Results date posted
| 2023 | Year | 06 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
primary FHT, with and without hydrops
Participant flow
Registration by questionnaire
Adverse events
None
Outcome measures
Presence/absence of hydrops fetalis, survival rate, presence/absence/method of fetal treatment, gestational age of onset, presence/absence of subcutaneous edema/ascites
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 20 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
retrospective cohort study by national questionnaire survey
Management information
Registered date
| 2013 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014511
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
