UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of analysis system for fetal heart rate variability using fetal heart Doppler sound obtained by ultrasound cardiograph
Title of the study (Brief title)	Study of fetal heart rate variability (FHRV)
Region	Japan

Condition
Condition	Pregnant women
Classification by specialty	Obsterics and gynecology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop a method to analyze in real time power spectra and cross-spectra from time series data of fetal and mother heart rate variability (HRV) which are recorded simultaneously and continuously
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Power spectra, cross-spectra and relative noise contribution from time series data of fetal and mother heart rate variability (HRV)
Key secondary outcomes	Health diagram to simultaneously monitor health state of fetus and mother in real time

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Health also makes a good pregnant woman the subject with the one of the doctor of obstetrics and gynecology.
Key exclusion criteria	The person who doesn't have leave of a doctor of obstetrics and gynecology
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshio Yoshida
Organization	University of Fukui
Division name	Department of Obstetrics and Gynecology
Address	23-3 Matsuoka,Shimoaiduki,Eiheiji-cho,Yoshida-gun,fukui,Japan
TEL	+81-776-61-8392
Email	yyoshida@u-fukui.ac.jp

Public contact
Name of contact person	Chiyo Tamamura
Organization	University of Fukui
Division name	Department of Obstetrics and Gynecology
Address	23-3 Matsuoka,Shimoaiduki,Eiheiji-cho,Yoshida-gun,fukui,Japan
TEL	+81-776-61-8392
Homepage URL
Email	chiyo@u-fukui.ac.jp

Sponsor
Institute	University of Fukui
Institute
Department

Funding Source
Organization	National University Corporation, Kyoto University.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 03 Day
Anticipated trial start date	2018 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	NO

Management information
Registered date	2018 Year 09 Month 06 Day
Last modified on	2018 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038816