UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036414 |
|---|---|
| Receipt number | 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 00:02:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
matsushimas@kochi-u.ac.jp
Sponsor or person
Institute
Kochi medical school hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041487
