UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027890 |
|---|---|
| Receipt number | R000031874 |
| Scientific Title | Registry study of fetal biological signal by new method via maternal abdominal wall using cloud. |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2019/03/29 15:06:08 |
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Basic information
Public title
Registry study of fetal biological signal by new method via maternal abdominal wall using cloud.
Acronym
Registry study of fetal biological signal by new method via maternal abdominal wall using cloud.
Scientific Title
Registry study of fetal biological signal by new method via maternal abdominal wall using cloud.
Scientific Title:Acronym
Registry study of fetal biological signal by new method via maternal abdominal wall using cloud.
Region
| Japan |
Condition
Condition
Pregnant woman and their fetus who satisfy following conditions.
1)Age: More than 20 years old (the time of informed consent )
2) Gestational age: More than 20 weeks but before delivery.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research is a registry study to collect measurement raw data including biological signals of fetus and maternal body.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
As a registry study, collecting 100 cases of measurement raw data from fetuses and maternal bodies who are more than 20 weeks but before delivery, and preparing databases for each group of gestational weeks.
Key secondary outcomes
1)Investigate the equivalence between the analyzed results by the cloud and the monitor 138(stand-alone type-device) which was done clinical trial.
2)Evaluate exploratory the potential of clinical application as a fetal ECG, through extracting and analyzing abdominal wall induced fetal electrocardiogram heart rate signal from collected measurement raw data by new fetal heart rate extraction program.
3)When concluded to recognize the potential of clinical application as a fetal ECG, propose the standard value of fetal electrocardiogram, based on data from this study.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Divide the 100 cases into the group of each following number of gestational weeks, to register each group 20 cases as a guide.
Group 1 :: gestational weeks from 20 to 23
Group 2 :: gestational weeks from 24 to 27
Group 3 :: gestational weeks from 28 to 31
Group 4 :: gestational weeks from 32 to 36
Group 5 :: gestational weeks from 37 to 41
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Pregnant woman who is having a prenatal checkup at Tohoku University Hospital.
2) Pregnant woman who agreed the informed consent in Japanese by document, before participants in this study.
3)Pregnant woman who is more than 20 years old.( the time of informed consent).
4)Pregnant woman and fetus, whose gestation ages more than 20 weeks but before delivery.
Note) Mother's condition must be stable.
It must be one hour or more before delivery.
Key exclusion criteria
1)Pregnant woman who needs legal representative or witness at the informed consent.
2) The socially vulnerable.
3) Pregnant woman and fetus who are judged by a principal research doctor or a research sharing doctor as be inappropriate to participate in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Kimura |
Organization
Tohoku University
Division name
Graduate School of Medicine Disability Science International Disciplinary Biomedical Engineering
Zip code
Address
9th Floor of the Building No.5 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7575
ykimura@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Kimura |
Organization
Tohoku University
Division name
Graduate School of Medicine, Disability Science International Disciplinary Biomedical Engineering
Zip code
Address
9th Floor of the Building No.5 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7575
Homepage URL
ykimura@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine, Disability Science International Disciplinary Biomedical Engineering
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research
And Development
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
Address
Tel
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
| 2017 | Year | 06 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) To hospital visitor of prenatal checkup, make an explanation of the present study, obtain the consent document.
2) Check whether to meet the selection criteria, perform patient registration.
3) Before or after a prenatal checkup, a pregnant woman is in a state of supine or lying position, using a gel sheet for attachment of dish-shaped electrode code, attach on the abdominal wall maximum 13 electrode codes and an electrode code with an earth for body.
4) At the time of measurement by the test equipment, using the birth surveillance equipment (ultrasonic Doppler method) to observe the condition of fetus, simultaneously collect the data.
5) Measurement must be done more than 10 minutes (About 10 minutes to 20 minutes).
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031874
| Research Plan | |
|---|---|
| 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 |
