UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034274 |
|---|---|
| Receipt number | R000038753 |
| Scientific Title | Development and validation of a cervical cancer screening training program for midwives |
| Date of disclosure of the study information | 2018/09/26 |
| Last modified on | 2019/09/06 11:16:45 |
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Basic information
Public title
Development and validation of a cervical cancer screening training program for midwives
Acronym
Pap smear taker training program for midwives
Scientific Title
Development and validation of a cervical cancer screening training program for midwives
Scientific Title:Acronym
Pap smear taker training program for midwives
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a cervical cancer screening training program for midwives and to evaluate the program through accuracy of the samples and women's comfort
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of unsatisfactory samples
evaluation by women
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Pap smear taking training program
1)6-10 speculum exams and 5 pap smear taking practices under supervision and 20 pap smear taking under supervision per a participating midwife
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Qualified midwives working for the Ministry of defence or the Self-defense force.
2)Women receiving speculum exams in normal postpartum at the National Defense Medical College Hospital
3)Women receiving pap smears at out-patient OB/GYN clinic at the National Defense Medical College Hospital
4)Women working for the Ministry of Defense or the Self-defense force (>=35years old) receiving pap smears at the National Defense Medical College Hospital
Key exclusion criteria
1)Midwives not working for the Ministry of Defense or the Self-defense force.
2)Women who do not agree to speculum exams or pap smears performed by trained midwives
3)Among women who receive pap smears at the National Defense Medical College Hospital, women
(1)in pregnancy
(2)without uterus
(3)bleeding on the day as abnormal bleeding
4)Other cases when OB/GYNs decide women should not receive a pap smear or a speculum exam by the trained midwives
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tokiko |
| Middle name | |
| Last name | Oishi |
Organization
Takasaki Univ. Of Health and Welfare
Division name
Nursing Dpt
Zip code
370-0033
Address
501 Nakaoorui Takasaki city
TEL
027352-1291
oishi-t@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tokiko |
| Middle name | |
| Last name | Oishi |
Organization
Takasaki Univ. Of Health and Welfare
Division name
Nursing Dpt
Zip code
370-0033
Address
501 Nakaoorui Takasaki city
TEL
027352-1291
Homepage URL
oishi-t@takasaki-u.ac.jp
Sponsor or person
Institute
National Defense Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research by Japan Society for the Promotion of Science
commissioned by MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Takaksaki univ. of Health and Welfare
Address
501 Nakaoorui Takasaki city, Gunma
Tel
027352-1291
kuwabara@takasaki-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
防衛医科大学校病院(埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 26 | 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
| 2018 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038753
