UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047081 |
|---|---|
| Receipt number | R000053688 |
| Scientific Title | The association of BNP and NT-proBNP in umbilical cord blood and amniotic fluid with fetal ultrasonographic parameters : a cross-sectional study |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2024/09/07 15:48:35 |
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Basic information
Public title
The association of BNP and NT-proBNP in umbilical cord blood and amniotic fluid with fetal ultrasonographic parameters : a cross-sectional study
Acronym
The association of BNP and NT-proBNP in umbilical cord blood and amniotic fluid with fetal ultrasonographic parameters : a cross-sectional study
Scientific Title
The association of BNP and NT-proBNP in umbilical cord blood and amniotic fluid with fetal ultrasonographic parameters : a cross-sectional study
Scientific Title:Acronym
The association of BNP and NT-proBNP in umbilical cord blood and amniotic fluid with fetal ultrasonographic parameters : a cross-sectional study
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the fetal ultrasonographic parameter which are associated with BNP and NT-proBNP levels in umbilical cord blood and amniotic fluid.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The fetal ultrasonographic parameter which are associated with BNP and NT-proBNP levels in umbilical cord blood and amniotic fluid.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1)Pregnant women planning to deliver at Tohoku University Hospital
(2)Delivery after 22 weeks of gestational age
(3) Caesarean delivery
(4)Who consent to participate in this study
Key exclusion criteria
(1)Stillbirth
(2)Incorrect information on gestational age at birth
(3)Fetal chromosomal abnormality
(4)Others(inadequate fetal ultrasonographic data, insufficient amount of sample etc.)
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | Tadakawa |
Organization
Tohoku University Hospital
Division name
Obstetrics and gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi
TEL
022-717-7251
marit9059140@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Hospital
Division name
Obstetrics and gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi
TEL
022-717-7251
Homepage URL
shoko.ni525@gmail.com
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
KAKENHI (Grants-in-Aid for Scientific Research (C))
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the fetal ultrasonographic parameter which are associated with BNP and NT-proBNP levels in umbilical cord blood and amniotic fluid.
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053688
