UMIN-CTR Clinical Trial

Basic information
Public title	Registry study of fetal biologicals signal by the new method via maternal abdominal wall.
Acronym	Registry study of fetal biologicals signal by the new method via maternal abdominal wall.
Scientific Title	Registry study of fetal biologicals signal by the new method via maternal abdominal wall.
Scientific Title:Acronym	Registry study of fetal biologicals signal by the new method via maternal abdominal wall.
Region	Japan

Condition
Condition	Pregnant women and their fetuses whose satisfy following conditions. 1)Age: More than 20 years old (the time of informed consent ) 2) Gestational age: from 20 weeks to delivery.
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For heart rate is one fetus of important items of fetal monitoring in perinatal care, the ultrasonic Doppler method is widely used, for the electrocardiographic measurement of the fetus, now, we measured the only expulsion just before It is only a direct induction method is possible. This method is adapted only during expulsion, since there is invasive to the fetus, required to grasp the ECG of the fetus by the accurate and simple measurement method as one of early fetal monitoring trimester or later It is. This study, this is a new registry study the clinical application of a fetal electrocardiogram abdominal wall inductive method aimed, by analyzing the collected measured raw data to confirm the usefulness of the fetal electrocardiogram was further stored it is planned to consider the setting of the fetal electrocardiogram reference value from the fetal electrocardiogram data in Japan. Thus, the present study are the registry studies aimed at collecting various data that assumes when it is marketed, by multilateral analysis of the collected data, type and frequency of arrhythmias in fetal , severity, and even transition such as these symptoms are associated with pregnancy course of the observed pregnant woman and the fetus is likely to be elucidated. Fetal ECG heart rate monitor to be used in the new abdominal wall induction method, from Japan are expected as new medical equipment, and has been developing with a view to commercially available abroad as future development expansion, joint international clinical trial (trial ) it also considered.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	As a registry study, we will use test equipment monitor 6X23 as well as pre- approval fetal heart rate monitor (monitor 138). We will correct 170 cases fetal and maternal measurement raw dates. Pregnancy women's gestation ages are from 20 weeks to before delivery. And we will create each gestation ages database.
Key secondary outcomes	The new method via maternal abdominal wall fetal electrocardiogram signal is extracted from measured raw dates corrected by new corrected program. We will analysis these. We will exploratory evaluate whether it can be clinical indications as fetal electrocardiogram. If it can be clinical indications as fetal electrocardiogram, we propose fetal electrocardiogram reference value from obtained dates in 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 170 cases in the group of each following number of weeks of pregnancy, to register each group 34 cases as a guide. Group 1 :: pregnancy 20 weeks to 23 weeks. Group 2 :: pregnancy 24 weeks to 27 weeks. Group 3 :: pregnancy 28 weeks to 31 weeks. Group 4 :: pregnancy 32 weeks to 36 weeks. Group 5 :: pregnancy 37 weeks to 41 weeks.
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) She agreed document in Japanese before participants in this study. 2) She is more than 20 years old ( the time of informed consent). 3)Pregnant woman and fetus whoes gestation ages from 20 weeks to delivery. Note) Her condition is stabilize. We consider her delivery more than 1 hour before.
Key exclusion criteria	1)When she agrees she need to legal representative or witness. 2) The socially vulnerable. 3) Other, research investigator or research sharing doctor decided pregnant woman and the fetus inappropriate to participate in the study.
Target sample size	170

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	Japan

Other related organizations
Co-sponsor	National Center for Child Health and Developmemt Keio University Hospital University of Miyazaki Hospital St. Marianna University School of Medicine
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	東北大学病院（宮城県）　Tohoku University 国立成育医療研究センター（東京都）National Center for Child Health and Developmemt 慶應義塾大学病院（東京都）Keio University Hospital 宮崎大学医学部附属病院（宮崎県）University of Miyazaki Hospital 聖マリアンナ医科大学病院（神奈川県）St. Marianna University School of Medicine

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 24 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	2015 Year 10 Month 30 Day
Date of IRB	2015 Year 07 Month 28 Day
Anticipated trial start date	2016 Year 03 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) visit in prenatal care, make an explanation of the present study, to obtain the consent document. 2) Check whether to meet the selection criteria, to perform patient registration. 3) pregnant women after prenatal care before or prenatal care in a state of supine or lying position, 13 maximum with a dish-shaped electrode code mounting gel sheet to pregnant women abdominal wall and I stuck a single electrode for body earth. 4) At the time of measurement by the test equipment, by using the delivery monitor (ultrasonic Doppler method) simultaneously observing the condition of the fetus, may be collected at the same time the data. 5) measurement, more than 10 minutes (about 10 minutes to 20 minutes) do.

Management information
Registered date	2015 Year 12 Month 22 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=R000023399