UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013891 |
|---|---|
| Receipt number | R000016119 |
| Scientific Title | The research about the effect of Magnesium Sulfate on vascular endothelial dysfunction, inflammation and oxidative stress in severe preeclampsia. |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2017/03/28 16:30:03 |
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Basic information
Public title
The research about the effect of Magnesium Sulfate on vascular endothelial dysfunction, inflammation and oxidative stress in severe preeclampsia.
Acronym
The research about the effect of Magnesium Sulfate on vascular endothelial dysfunction, inflammation and oxidative stress in severe preeclampsia.
Scientific Title
The research about the effect of Magnesium Sulfate on vascular endothelial dysfunction, inflammation and oxidative stress in severe preeclampsia.
Scientific Title:Acronym
The research about the effect of Magnesium Sulfate on vascular endothelial dysfunction, inflammation and oxidative stress in severe preeclampsia.
Region
| Japan |
Condition
Condition
preeclampsia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of our study is examining whether Magnesium Sulfate decreases maternal serum soluble fms like tyrosine kinase 1, Tumor Necrosis Factor 1 and urine F2 Isoprostanes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maternal serum soluble fms-like tyrosine kinase 1
Maternal serum Tumor Necrosis Factor 1
Maternal urine F2-Isoprostanes
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous administration of Magnesium sulfate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The patients who was diagnosed with preeclampsia should be included.
Key exclusion criteria
The patients who are suffered from myasthenia gravis, cardiac block and hypotonic dehydration which are contraindication for Magnesium Sulfate should be excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Konishi |
Organization
Kyoto University
Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-3269
konish@ikuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Kawasaki |
Organization
Kyoto University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-3269
Homepage URL
kkaoru@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Graduate School of medicine
Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Graduate School of Medicine
Obstetrics and Gynecology
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
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
| 2014 | Year | 06 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | 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
Management information
Registered date
| 2014 | Year | 05 | Month | 06 | Day |
Last modified on
| 2017 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016119
