UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014489 |
|---|---|
| Receipt number | R000016851 |
| Scientific Title | The change of endothelial function of preeclampsia patients during the treatments |
| Date of disclosure of the study information | 2014/07/14 |
| Last modified on | 2020/01/09 09:43:16 |
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Basic information
Public title
The change of endothelial function of preeclampsia patients during the treatments
Acronym
Endothelial dysfunction of preeclampsia
Scientific Title
The change of endothelial function of preeclampsia patients during the treatments
Scientific Title:Acronym
Endothelial dysfunction of preeclampsia
Region
| Japan |
Condition
Condition
preeclampsia and pregnancy induced hypertension
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the treatments for preeclampsia (bed rest, blood pressure-lowering drugs, and MgSO4) improve the endothelial dysfunction in preeclmapsia patients.
Basic objectives2
Others
Basic objectives -Others
To evaluate whether the improvement of endothelial dysfuntion contributes the better perinatal prognosis.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the change of endothelial function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
normal, no medication
Interventions/Control_2
pregnancy induced hypertension, bed rest, blood pressure-lowering drugs
Interventions/Control_3
preeclampsia, bed rest, blood pressure-lowering drugs, MgSO4
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
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnancy induced hypertension and preeclampsia.
Key exclusion criteria
the cases with complication of pheochromocytoma.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Ohmichi |
Organization
Osaka Medical College
Division name
Obstetrics and Gynecology
Zip code
Address
2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
TEL
+81-72-683-1221
m-ohmichi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Tanabe |
Organization
Osaka Medical College
Division name
Obstetrics and Gynecology
Zip code
Address
2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
TEL
+81-72-683-1221
Homepage URL
gyn074@osaka-med.ac.jp
Sponsor or person
Institute
Dept. of Obstetrics and Gynecology
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Dept. of Obstetrics and Gynecology
Osaka Medical College
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 | 07 | Month | 14 | 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 | 07 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016851
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/01/08 | PE_FMDプロトコル.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/01/08 | 岡本研究計画書H26年度.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/01/08 | 成果発表会2016.pptx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/16851
