UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056187 |
|---|---|
| Receipt number | R000064207 |
| Scientific Title | The effect of orexin levels and vascular endothelial dysfunction in pregnant women with hypertensive disorder of pregnancy (HDP); A single-center prospective cohort study |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2024/11/19 02:43:16 |
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Basic information
Public title
The effect of orexin in hypertensive disorder of pregnancy (HDP)
Acronym
HDP and Orexin Study
Scientific Title
The effect of orexin levels and vascular endothelial dysfunction in pregnant women with hypertensive disorder of pregnancy (HDP); A single-center prospective cohort study
Scientific Title:Acronym
EOV in HDP study
Region
| Japan |
Condition
Condition
hypertensive disorder of Pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will assess mental stress, blood orexin levels, body blood pressure, vascular endothelial function, metabolism and blood oxidative stress levels in normal non-fertile women, normal pregnant women and hypertensive pregnant women. The purpose of these evaluations is to determine the relationship between maternal psychopathology and orexin, and furthermore to determine whether this relationship is linked to cardiovascular pathology in pregnant women.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate blood orexin levels in normal pregnant women and pregnant women with hypertensive disorder of pregnancy and in non-pregnant women. (Normal pregnant women at 34 weeks. Pregnant women with hypertensive disorder of pregnancy will be evaluated at the time of disease onset.)
Key secondary outcomes
Evaluate blood ROS levels, vascular endothelial function, and stress levels in normal pregnant women and pregnant women with hypertensive disorder of pregnancy and in non-pregnant women.(Normal pregnant women at 34 weeks. Pregnant women with hypertensive disorder of pregnancy will be evaluated at the time of disease onset.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Pregnant women with hypertensive disorder of pregnancy will be included.
Blood sampling, vascular endothelial function test, and stress evaluation will be performed at diagnosis, before delivery, and 4 days after delivery.
Interventions/Control_2
Normal pregnant women will be included.
Blood sampling, vascular endothelial function test, and stress evaluation will be performed before delivery and 4 days after delivery.
Interventions/Control_3
Non-pregnant women will be included.
Blood sampling, vascular endothelial function test, and stress evaluation will be performed.
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
| 16 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant women with hypertensive disorder of pregnancy: Pregnant women with hypertensive disorder of pregnancy (HDP)
Normal pregnant women: Uncomplicated pregnant women (after 36 weeks)
Non-pregnant women: Non-pregnant women without complications
Key exclusion criteria
Pregnant women with hypertensive disorder of pregnancy: non-pregnant BMI less than 18 and greater than 25. Pregnant women with a chronic disease or history of a chronic disease that could affect pregnancy (diabetes, cardiac disease, respiratory disease, endocrine disease, etc.)
Normal pregnant women: BMI less than 18, BMI greater than 25
Non-pregnant women: BMI less than 18, BMI greater than 25
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | kazushi |
| Middle name | |
| Last name | watanabe |
Organization
Aichi Medical University School of Medicine
Division name
Departments of Obstetrics and Gynecology
Zip code
4801195
Address
1-1 yazako karimata, Nagakute City, Aichi Prefecture, Japan
TEL
+81-561-62-3311
kw446433@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | tomohito |
| Middle name | |
| Last name | okamoto |
Organization
Aichi Medical University School of Medicine
Division name
Departments of Obstetrics and Gynecology
Zip code
4801195
Address
1-1 yazako karimata, Nagakute City, Aichi Prefecture, Japan
TEL
+81-561-62-3311
Homepage URL
okamoto.tomohito.696@mail.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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University Hospital Clinical Research and Audit Office, Department of Hospital Affairs
Address
1-1 yazako karimata, Nagakute City, Aichi Prefecture, Japan
Tel
+81-561-62-3311
amu_crb@aichi-med-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
| 2024 | Year | 11 | Month | 30 | 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
88
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
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064207
