UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041645 |
|---|---|
| Receipt number | R000047534 |
| Scientific Title | Relationship between Maternal Blood Protein Concentration and Reactive Oxygen and Vascular Endothelial Function in Hypertensive disorders of pregnancy(HDP) Pregnant Women |
| Date of disclosure of the study information | 2020/09/02 |
| Last modified on | 2020/09/02 10:32:51 |
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Basic information
Public title
Relationship between Maternal Blood Protein Concentration and Reactive Oxygen and Vascular Endothelial Function in Hypertensive disorders of pregnancy (HDP) Pregnant Women
Acronym
Relationship between Maternal Blood Protein Concentration and Reactive Oxygen and Vascular Endothelial Function in Hypertensive disorders of pregnancy(HDP) Pregnant Women
Scientific Title
Relationship between Maternal Blood Protein Concentration and Reactive Oxygen and Vascular Endothelial Function in Hypertensive disorders of pregnancy(HDP) Pregnant Women
Scientific Title:Acronym
Relationship between Maternal Blood Protein Concentration and Reactive Oxygen and Vascular Endothelial Function in Hypertensive disorders of pregnancy(HDP) Pregnant Women
Region
| Japan |
Condition
Condition
Pregnant women with
Preeclampsia
Gestatonal hypertension
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the serum levels of free radical, as well as albumin and those impact on the flow-mediated dilation (FMD) reflecting vascular endothelial function in patients with preeclampsia (PE) and gestational hypertension (GH).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The serum levels of free radical, as well as albumin and those impact on the flow-mediated dilation (FMD) reflecting vascular endothelial function in patients with preeclampsia (PE) and gestational hypertension (GH).
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
| 34 | years-old | >= |
Gender
Female
Key inclusion criteria
PE was defined systolic blood pressure (BP) >=140 mmHg or diastolic BP>=90 mmHg after 20 weeks gestation, proteinuria (>=300 mg protein/24 hours), other maternal organ dysfunction, and uteroplacental dysfunction. GH was defined systolic BP >=140 mmHg or diastolic BP>=90 mmHg after 20 weeks gestation.
Key exclusion criteria
The participants smoked, consumed alcohol or caffeine, or had a history of thyroid disease, hypertension, diabetes mellitus, hyperlipidemia, or liver disease and were not taking any medications known to influence lipoprotein metabolism.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Saitou |
| Middle name | |
| Last name | Takuya |
Organization
Aichi Medical University School of
Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
480-1195
Address
Nagakute-city, Aichi 480-1195, Japan
TEL
0561-62-3311
saito1023@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Saitou |
| Middle name | |
| Last name | Takuya |
Organization
Aichi Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
480-1195
Address
Nagakute-city, Aichi 480-1195, Japan
TEL
0561-62-3311
Homepage URL
saito1023@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University School of
Medicine
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University School of
Medicine
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
Aichi Medical University School of
Address
Nagakute-city, Aichi 480-1195, Japan
Tel
0561-62-3311
aichi-med@esct.bvits.com
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
| 2020 | Year | 09 | Month | 02 | 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
75
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2020 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047534
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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