UMIN-CTR Clinical Trial

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	Obsterics 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
Last 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
Email	ykimura@med.tohoku.ac.jp

Public contact
1st 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
Email	ykimura@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine, Disability Science International Disciplinary Biomedical Engineering
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031874