UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042803 |
|---|---|
| Receipt number | R000048869 |
| Scientific Title | A study on the autonomic nervous function in pregnant women by evaluating finger point pulse wave |
| Date of disclosure of the study information | 2020/12/22 |
| Last modified on | 2024/12/24 09:08:22 |
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Basic information
Public title
A study on the autonomic nervous function in pregnant women by evaluating finger point pulse wave
Acronym
A study on the autonomic nervous function in pregnant women by evaluating finger point pulse wave
Scientific Title
A study on the autonomic nervous function in pregnant women by evaluating finger point pulse wave
Scientific Title:Acronym
A study on the autonomic nervous function in pregnant women by evaluating finger point pulse wave
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate whether it is possible to evaluate autonomic nerve function in pregnant women by measuring the finger point pulse wave.
Basic objectives2
Others
Basic objectives -Others
Verification of measurement results in pregnant women
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To characterize autonomic nervous system function in pregnant women by finger point pulse wave
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant women who come to the hospital for prenatal health checkup or examination, and who have given written informed consent.
Key exclusion criteria
Pregnant women who do not give written informed consent
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakata |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
masahiko.nakata@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakata |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
masahiko.nakata@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
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
Toho University Omori Medical Center
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
Tel
03-3762-4151
omori.rinri@ext.toho-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
| 2020 | Year | 12 | Month | 22 | 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
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
In this study, we will evaluate the autonomic nervous system activity level from the finger point pulse wave of pregnant, and examine whether it shows a characteristic trend at each stage of pregnancy and whether it is related to the occurrence of hypertensive disorders of pregnancy, fetal growth restriction, and mental health problems, as well as to pregnancy and perinatal prognosis.
Management information
Registered date
| 2020 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048869
