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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030566
Receipt No. R000034900
Scientific Title Study for maternal and fetal circulation in perinatal period
Date of disclosure of the study information 2018/01/01
Last modified on 2017/12/26

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Basic information
Public title Study for maternal and fetal circulation in perinatal period
Acronym Study for maternal and fetal circulation in perinatal period
Scientific Title Study for maternal and fetal circulation in perinatal period
Scientific Title:Acronym Study for maternal and fetal circulation in perinatal period
Region
Japan

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

Objectives
Narrative objectives1 To establish optimal management strategy in the perinatal period by using maternal and fetal biometric information
Basic objectives2 Others
Basic objectives -Others a comprehensive analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes biometric information for optimal management
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
20 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria pregnant woman and neonate
Key exclusion criteria a person who does not give an informed consent
Target sample size 1500

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 Omorinishi, Ota-ku, Tokyo
TEL 03-3762-4151
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 Omorinishi, Ota-ku, Tokyo
TEL 03-3762-4151
Homepage URL
Email masahiko.nakata@med.toho-u.ac.jp

Sponsor
Institute Toho University Omori Medical Center
Institute
Department

Funding Source
Organization Toho University Omori Medical Center
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
2018 Year 01 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information opening

Management information
Registered date
2017 Year 12 Month 26 Day
Last modified on
2017 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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