Registry study of fetal biological signal by new method via maternal abdominal wall using cloud.
Not Applicable
- Conditions
- 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.
- Registration Number
- JPRN-UMIN000027890
- Lead Sponsor
- Tohoku University Graduate School of Medicine, Disability Science International Disciplinary Biomedical Engineering
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.