UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050851 |
|---|---|
| Receipt number | R000057950 |
| Scientific Title | A Study of Fetal Heart Rate Monitoring in Pregnant Women under Automobile Driving Conditions |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2025/10/14 10:08:32 |
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Basic information
Public title
A Study of Fetal Heart Rate Monitoring in Pregnant Women under Automobile Driving Conditions
Acronym
A Study of Fetal Heart Rate Monitoring in Pregnant Women under Automobile Driving Conditions
Scientific Title
A Study of Fetal Heart Rate Monitoring in Pregnant Women under Automobile Driving Conditions
Scientific Title:Acronym
A Study of Fetal Heart Rate Monitoring in Pregnant Women under Automobile Driving Conditions
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between monitored uterine contractions and fetal heart rate variability by obtaining vehicle driving parameters during driving for pregnant women who drive a car on a daily basis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Driving conditions
Uterine contractions and fetal heart rate
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
| Not applicable |
Gender
Female
Key inclusion criteria
10 pregnant women who are accustomed to wearing a fetal heart rate transducer at 30 to 36 weeks' gestation and who regularly drive a car in their daily lives
Key exclusion criteria
Pregnant women with complications of impending preterm labor, gestational hypertension, or gestational diabetes
Pregnant women who are not driving a motor vehicle at any time
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Tateoka |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing, Maternal Nursing and Midwifery
Zip code
5202192
Address
Tsukinowa, Seta, Otsu, Shiga 520-2192 Japan
TEL
0775482433
ytateoka@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Oe |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing, Maternal Nursing and Midwifery
Zip code
5202192
Address
Tsukinowa, Seta, Otsu, Shiga 520-2192 Japan
TEL
0775482391
Homepage URL
ryoko55@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
Tsukinowa, Seta, Otsu, Shiga 520-2192 Japan
Tel
0775483576
hqrec@belle.shiga-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R2020-148
Org. issuing International ID_1
Shiga University of Medical Science
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | 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
| 2021 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects will be those who meet the selection criteria and give consent for the research within the research period.
Management information
Registered date
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057950
