Exploratory study of fetal EEG signal extraction technology using existing data by maternal abdominal wall.

Exploratory study of fetal EEG signal extraction technology using existing data by maternal abdominal wall. - Exploratory study of fetal EEG signal extraction technology using existing data by maternal abdominal wall.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043555

Enrollment

426

Registered

2021-04-01

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Use existing information

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Data collected from two clinical studies and one clinical trial conducted at Tohoku University Hospital in the past will be included. 1.Title of research: Clinical research using fetal electrocardiogram Research period: August 2009 - March 2019 Date of approval(most recent): April 11, 2014 (receipt number: 2014-1-23) Number of cases: 245 2.Title of the study: Registry study of fetal bio-signals using a new abdominal wall guidance method Research period: August 2015 - March 2019 Date of approval(most recent): December 12, 2018 (receipt number: 2018-2-242) Number of cases: 158 cases (only cases registered at Tohoku University Hospital) 3.Clinical trial title: Efficacy and safety evaluation study of Monitor 138 Clinical trial period: February, 2013 - January, 2015 Number of cases: 23

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Frequency spectrum analysis is performed to confirm that the results extracted from the RAW data of biological signals by the maternal abdominal wall induction method are fetal-derived EEG signals. In addition, the fetal heart rate obtained at the same time is evaluated. In addition, the stage of sleep of the fetus is estimated from the fetal heart rate chart obtained at the same time, and the relationship with EEG is examined and evaluated.	—

Measure

Time frame

Frequency spectrum analysis is performed to confirm that the results extracted from the RAW data of biological signals by the maternal abdominal wall induction method are fetal-derived EEG signals. In addition, the fetal heart rate obtained at the same time is evaluated. In addition, the stage of sleep of the fetus is estimated from the fetal heart rate chart obtained at the same time, and the relationship with EEG is examined and evaluated.

—

Countries

Japan

Contacts

Public ContactYoshiyuki Kasahara

Tohoku University Department of Maternal and Child Health Care Medical Science, Graduate School of Medicine

kasa@med.tohoku.ac.jp022-717-7575

Outcome results