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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036414
Receipt No. R000041487
Scientific Title The study of fetal and placental blood flow improvement effect with the deep ocean water
Date of disclosure of the study information 2019/04/05
Last modified on 2019/04/05

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Basic information
Public title The study of fetal and placental blood flow improvement effect with the deep ocean water
Acronym The study of fetal and placental blood flow improvement effect with the deep ocean water
Scientific Title The study of fetal and placental blood flow improvement effect with the deep ocean water
Scientific Title:Acronym The study of fetal and placental blood flow improvement effect with the deep ocean water
Region
Japan

Condition
Condition fetal grouth restriction
Hypertensive disorder of pregnancy
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Deep Ocean Water(DOW) can inhibit hypertensive disorder, the fetal grouth restriction onset or thinks about whether the prevalence of the low birth weight infants is reduced.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the prevalence of hypertensive disorder
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Deep ocean water 500ml per day
Interventions/Control_2 normal water 500ml per day
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 pregnant women treated in our hospital
Key exclusion criteria heart failure,renal failure,allergy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Sachio
Middle name
Last name Matsushima
Organization Kochi medical school hospital
Division name Obstetrics and Gynecology
Zip code 783-8505
Address nankoku city,kochi prefecture
TEL 088-880-2383
Email matsushimas@kochi-u.ac.jp

Public contact
Name of contact person
1st name Sachio
Middle name
Last name Matsushima
Organization Kochi medical school hospital
Division name Obstetrics and Gynecology
Zip code 783-8505
Address nankoku city,kochi prefecture
TEL 088-880-2383
Homepage URL
Email matsushimas@kochi-u.ac.jp

Sponsor
Institute Kochi medical school hospital
Institute
Department

Funding Source
Organization AKO KASEI corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kochi medical school hospital
Address nankoku city,kochi prefecture
Tel 088-880-2383
Email matsushimas@kochi-u.ac.jp

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
2019 Year 04 Month 05 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 05 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041487

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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