UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052569 |
|---|---|
| Receipt number | R000057668 |
| Scientific Title | Establishment of new amniotic fluid biomarkers that reflect the short- and long-term prognosis of fetal growth restriction children |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/03/27 10:56:57 |
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Basic information
Public title
Establishment of new amniotic fluid biomarkers that reflect the short- and long-term prognosis of fetal growth restriction children
Acronym
Establishment of new amniotic fluid biomarkers that reflect the short- and long-term prognosis of fetal growth restriction children
Scientific Title
Establishment of new amniotic fluid biomarkers that reflect the short- and long-term prognosis of fetal growth restriction children
Scientific Title:Acronym
Establishment of new amniotic fluid biomarkers that reflect the short- and long-term prognosis of fetal growth restriction children
Region
| Japan |
Condition
Condition
fetal growth restriction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to verify whether next-generation urinary biomarkers can predict short- and long-term prognosis of fetal growth restriction using amniotic fluid from fetal growth restriction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fetal death, neonatal and infant death, neurological development at 2 years of age (cerebral palsy, severe developmental delay)
Key secondary outcomes
hospitalization in the neonatal intensive care unit, respiratory distress syndrome, artificial respiration, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, cerebral hemorrhage, periventricular leukomalacia, visual and hearing impairment at 2 years of age
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 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
singleton pregnancies with fetal growth restriction
more than 22 weeks of gestation
Key exclusion criteria
severe fetal malformations, lethal fetal chromosomal abnormalities, and multiple pregnancies
abruption of placenta, prolapse of umbilical cord, non reassuring fetal status, massive genital hemorrhage due to placenta previa, uterine rupture, and other feto-maternal emergent status
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Katsura |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
5202192
Address
tsukinowa-cho, seta, otsu city, Shiga prefecture
TEL
077-548-2267
katsuo14@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Katsura |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
5202192
Address
tsukinowa-cho, seta, otsu city, Shiga prefecture
TEL
077-548-2267
Homepage URL
katsuo14@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Department of Obstetrics and Gynecology
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
Shiga University of Medical Science
Address
tsukinowa-cho, seta, otsu city, Shiga prefecture
Tel
077-548-2267
katsuo14@belle.shiga-med.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
滋賀医科大学（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 01 | 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
| 2023 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2023 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057668
