UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025909 |
|---|---|
| Receipt number | R000029766 |
| Scientific Title | Development of a new monitoring system using a FBG(Fiber Bragg Grating) sensor for fetal movement and fetal heart rate. |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2021/12/27 16:34:00 |
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Basic information
Public title
Development of a new monitoring system using a FBG(Fiber Bragg Grating) sensor for fetal movement and fetal heart rate.
Acronym
Development of a monitoring system using a FBG sensor for fetal movement and fetal heart rate.
Scientific Title
Development of a new monitoring system using a FBG(Fiber Bragg Grating) sensor for fetal movement and fetal heart rate.
Scientific Title:Acronym
Development of a monitoring system using a FBG sensor for fetal movement and fetal heart rate.
Region
| Japan |
Condition
Condition
non-reassuring fetal status
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a simple and easy new monitoring system using a FBG sensor for fetal movement and fetal heart rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance of results of fetal movement and fetal heart rate using a FBG sensor and results of real fetal movement and fetal heart rate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We attach optical fiber of a diameter of around 0.1mm to pregnant women's abdomen in medical tape, and measure fetal movement and fetal heart rate for 20-40 minutes.
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
In the Shinshu University Hospital, the pregnant outpatients or pregnant inpatients who are after 24 weeks of gestation and signed consent form after enough explanation of this investigation.
Key exclusion criteria
nothing particular
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kanai |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL
81-263-37-2399
makotok@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinshu University School of Medicine |
| Middle name | |
| Last name | the Committee for Medical Ethics |
Organization
Shinshu University
Division name
the Committee for Medical Ethics of Shinshu University School of Medicine
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL
81-263-37-2399
Homepage URL
mdrinri@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
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
the Committee for Medical Ethics of Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
Tel
81-263-35-4600
mdrinri@shinshu-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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 30 | Day |
Last modified on
| 2021 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029766
