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.
Conditions
Interventions
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 week
Sponsors
Tohoku University Graduate School of Medicine, Disability Science International Disciplinary Biomedical Engineering
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactYoshitaka Kimura
Tohoku University Graduate School of Medicine, Disability Science International Disciplinary Biomedical Engineering
Outcome results
None listed