UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020308
Receipt number R000023399
Scientific Title Registry study of fetal biologicals signal by the new method via maternal abdominal wall.
Date of disclosure of the study information 2015/12/24
Last modified on 2019/03/29 15:03:43

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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

Obstetrics 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

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

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 or person

Institute

Tohoku University Graduate School of Medicine Disability Science
International Disciplinary Biomedical Engineering

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023399


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name