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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016592
Receipt No. R000019253
Scientific Title The study of the measurement of fetal heart rate by using ultrasonography.
Date of disclosure of the study information 2015/02/20
Last modified on 2017/04/18

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Basic information
Public title The study of the measurement of fetal heart rate by using ultrasonography.
Acronym The study of fetal heart rate
Scientific Title The study of the measurement of fetal heart rate by using ultrasonography.
Scientific Title:Acronym The study of fetal heart rate
Region
Japan

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

Objectives
Narrative objectives1 Assessment of the pregnancy outcome and fetal mortality by measurement of the fetal heart rate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pregnancy outcome, abortion rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of fetal heart rate counts for fifty pregnant women.
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
16 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria pregnant women
Key exclusion criteria When an agreement for the declaration of consent is not provided.

When a pregnant women has a mental disorder.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Murata
Organization Kawasaki Medical School
Division name Obstetrics and Gynecology
Zip code
Address 577 matsushima, kurashiki, Okayama
TEL 086-462-1111
Email smurata@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Murata
Organization Kawasaki Medical School
Division name Obstetrics and Gynecology
Zip code
Address 577 matusshima, Kurashiki, Okayama
TEL 086-462-1111
Homepage URL
Email smurata@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 20 Day
Last follow-up date
2017 Year 04 Month 18 Day
Date of closure to data entry
2017 Year 04 Month 18 Day
Date trial data considered complete
2017 Year 04 Month 18 Day
Date analysis concluded
2017 Year 04 Month 18 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 20 Day
Last modified on
2017 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019253

Research Plan
Registered date File name
2017/02/21 研究実施計画書平成28年6月改訂版ver1.1.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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