UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	mdrinri@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029766