UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050614 |
|---|---|
| Receipt number | R000057539 |
| Scientific Title | A study of the new reference value for estimated fetal weight in Japan |
| Date of disclosure of the study information | 2023/03/17 |
| Last modified on | 2023/03/17 10:36:13 |
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Basic information
Public title
A study of the new reference value for estimated fetal weight in Japan
Acronym
New Reference Value for EFW in Japan
Scientific Title
A study of the new reference value for estimated fetal weight in Japan
Scientific Title:Acronym
New Reference Value for EFW in Japan
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to create a new reference values for fetal ultrasound parameters prospectively.
Basic objectives2
Others
Basic objectives -Others
ultrasound parameters will be prospectively collected from multiple. The ultrasound parameters will be analyzed using a regression model with the response variable (Y) and the number of weeks of gestation as the predictor variable (X), and reported as reference values for each parameter.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the reference range of estimated fetal weight by gestational week.
Key secondary outcomes
The secondary outcome are the reference range of BPD, HC, AC, and FL by gestational week.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The eligibility criteria for this study are women who are at least 18 years of age with a singleton pregnancy and whose expected delivery date is determined according to the "Guidelines for Obstetrics and Gynecology Practice, Obstetrics Edition 2020 (latest edition once the revised edition is released)" and whose ultrasound measurements are measured at the reference plane.
Key exclusion criteria
Patients whose ultrasound measurements are not measured at the reference plane.
Patients referred for medical reasons after the 2nd trimester at institutions with a NICU or MFICU (non-medical reasons such as relocation are acceptable).
Patients who are inappropriate for this study.
Target sample size
2600
Research contact person
Name of lead principal investigator
| 1st name | Sumito |
| Middle name | |
| Last name | Nagasaki |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-8541
Address
6-11-1 Omori-nishi ota-ku Tokyo Japan
TEL
03-3762-4151
sumito.nagasaki@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Sumito |
| Middle name | |
| Last name | Nagasaki |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-8541
Address
6-11-1 Omori-nishi ota-ku Tokyo Japan
TEL
03-3762-4151
Homepage URL
sumito.nagasaki@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Sumito Nagasaki
Funding Source
Organization
none
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
ethics committee of Toho University
Address
5-21-16 omori-nishi ot-ku Tokyo Japan
Tel
03-5763-6034
med.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
東邦大学医療センター大森病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 17 | 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
1300
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
| 2023 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to create reference values for fetal ultrasound parameters using an internationally agreed-upon creation method. Specifically, we will collect ultrasound parameters from multiple institutions in a forward-looking manner, analyze them using a regression model with ultrasound parameters as the response variable (Y) and the number of weeks of gestation as the predictor variable (X), and report the reference values for each parameter.
Management information
Registered date
| 2023 | Year | 03 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057539
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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