Unique ID issued by UMIN | UMIN000020308 |
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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 |
Registry study of fetal biologicals signal by the new method via maternal abdominal wall.
Registry study of fetal biologicals signal by the new method via maternal abdominal wall.
Registry study of fetal biologicals signal by the new method via maternal abdominal wall.
Registry study of fetal biologicals signal by the new method via maternal abdominal wall.
Japan |
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.
Obstetrics and Gynecology |
Others
NO
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.
Efficacy
Exploratory
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.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Prevention
Device,equipment |
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.
20 | years-old | <= |
Not applicable |
Female
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.
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.
170
1st name | |
Middle name | |
Last name | Yoshitaka Kimura |
Tohoku University
Graduate School of Medicine Disability Science International Disciplinary Biomedical Engineering
9th Floor of the Building No.5 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
022-717-7575
ykimura@med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Yoshitaka Kimura |
Tohoku University
Graduate School of Medicine Disability Science International Disciplinary Biomedical Engineering
9th Floor of the Building No.5 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
022-717-7575
ykimura@med.tohoku.ac.jp
Tohoku University Graduate School of Medicine Disability Science
International Disciplinary Biomedical Engineering
Japan Agency for Medical Research
And Development
Other
Japan
National Center for Child Health and Developmemt
Keio University Hospital
University of Miyazaki Hospital
St. Marianna University School of Medicine
NO
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
2015 | Year | 12 | Month | 24 | Day |
Unpublished
Completed
2015 | Year | 10 | Month | 30 | Day |
2015 | Year | 07 | Month | 28 | Day |
2016 | Year | 03 | Month | 01 | Day |
2019 | Year | 03 | Month | 29 | Day |
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.
2015 | Year | 12 | Month | 22 | Day |
2019 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023399
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