UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028948 |
|---|---|
| Receipt number | R000033123 |
| Scientific Title | Study to develop a novel feto-maternal monitoring system with high sensitive sensor |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2021/03/04 13:47:50 |
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Basic information
Public title
Study to develop a novel feto-maternal monitoring system with high sensitive sensor
Acronym
Study to develop a novel feto-maternal monitoring system
Scientific Title
Study to develop a novel feto-maternal monitoring system with high sensitive sensor
Scientific Title:Acronym
Study to develop a novel feto-maternal monitoring system
Region
| Japan |
Condition
Condition
preterm labor
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a new system that can monitor uterine contraction and fetal movement with high sensitivity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective recording of the uterine contraction and fetal movement
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
monitoring using new equipment (60 min)
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
pregnant woman with written informed consent was obtained
Key exclusion criteria
fetal anomaly, multiple gestation, intrauterine fetal death
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Miyasaka |
Organization
Tokyo Medical and Dental University
Division name
comprehensive reproductive medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
n.miyasaka.gyne@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Miyasaka |
Organization
Tokyo Medical and Dental University
Division name
comprehensive reproductive medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
Homepage URL
n.miyasaka.gyne@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
YAMAHA
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
BERC
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
syomu1.adm@tmd.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 | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033123
