UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056208 |
|---|---|
| Receipt number | R000064121 |
| Scientific Title | Changes in smoking behavior of pregnant women and their husbands using urinary cotinine measurements. |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/06/05 10:07:35 |
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Basic information
Public title
Changes in smoking behavior of pregnant women and their husbands using urinary cotinine measurements.
Acronym
Changes in smoking behavior using urinary cotinine measurements.
Scientific Title
Changes in smoking behavior of pregnant women and their husbands using urinary cotinine measurements.
Scientific Title:Acronym
Changes in smoking behavior using urinary cotinine measurements.
Region
| Japan |
Condition
Condition
environmental tobacco exposure
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in smoking behavior, passive smoking status, and perceptions and thoughts about smoking tobacco products, including heated tobacco products, using feedback of urinary cotinine levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Husband (partner) smoking status and passive smoking status of pregnant women.
Key secondary outcomes
Knowledge, perceptions, and attitude toward smoking among pregnat women
Knowledge, perceptions, and attitude toward smoking among husband
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Notification of urinary cotinine levels to pregnant women and their husbands (partners) in the intervention group.
Interventions/Control_2
Provide documentation on the effects of passive smoking of tobacco products, including heated tobacco, to both intervention and control groups
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
Male and Female
Key inclusion criteria
Non smoking pregnant women with normal pregnancies who have undergone antenatal checkups and their husbands who are current smokers
Key exclusion criteria
Participants who have difficulty communication in Japanese
Participants who cannot obtain consent from pregnant women or their husbands
Participants who cannot complete three rounds of questionnaires and urinalysis
Target sample size
428
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Shinozaki |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
3710034
Address
3-39-22 Showa-machi, Maebashi-city
TEL
027-220-8970
h_shinozaki@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Shinozaki |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
3710034
Address
3-39-22 Showa-machi, Maebashi-city
TEL
027-220-8970
Homepage URL
h_shinozaki@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Gunma University Graduate School of Health Sciences
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
Gunma University Graduate School of Health Sciences
Address
3-39-22 Showa-machi, Maebashi-city
Tel
027-220-8970
h_shinozaki@gunma-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
| 2025 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
IRB application currently pending
Management information
Registered date
| 2024 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064121
