UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026656
Receipt number R000030611
Scientific Title The study for evaluation of fetal cardiac function
Date of disclosure of the study information 2017/03/23
Last modified on 2017/04/20 13:22:50

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Basic information

Public title

The study for evaluation of fetal cardiac function

Acronym

Fetal cardiac funciton

Scientific Title

The study for evaluation of fetal cardiac function

Scientific Title:Acronym

Fetal cardiac funciton

Region

Japan


Condition

Condition

singleton pregnancy

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the novel technique for fetal cardiac function by ultrasonography

Basic objectives2

Others

Basic objectives -Others

To evaluate fetal echocardiography

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

To construct normal range

Key secondary outcomes



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

16 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

singleton pregnancy

Key exclusion criteria

fetal anomaly, multiple pregnancies

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiko Nakata

Organization

Toho University Omori Medical Center

Division name

Department of Obstetrics and Gynecology

Zip code


Address

6-11-1 Omori-Nishi, Ota-Ku, Tokyo

TEL

+81-3-3762-4151

Email

masahiko.nakata@med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiko Nakata

Organization

Toho University Omori Medical Center

Division name

Department of Obstetrics and Gynecology

Zip code


Address

6-11-1 Omori-Nishi, Ota-Ku, Tokyo

TEL

+81-3-3762-4151

Homepage URL


Email

masahiko.nakata@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University Omori Medical Center

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

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

2017 Year 03 Month 23 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

Completed

Date of protocol fixation

2015 Year 11 Month 11 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 11 Day

Last follow-up date

2017 Year 03 Month 01 Day

Date of closure to data entry

2017 Year 03 Month 23 Day

Date trial data considered complete

2017 Year 03 Month 23 Day

Date analysis concluded

2017 Year 03 Month 31 Day


Other

Other related information

in preparation


Management information

Registered date

2017 Year 03 Month 23 Day

Last modified on

2017 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030611


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name