UMIN-CTR Clinical Trial

Basic information
Public title	Development and evaluation of a cervical cancer screening training program for midwives in Japan
Acronym	Pap smear taker training program for midwives
Scientific Title	Development and evaluation of a cervical cancer screening training program for midwives in Japan
Scientific Title:Acronym	Pap smear taker training program for midwives
Region	Japan

Condition
Condition	cervical cancer
Classification by specialty	Obsterics and gynecology Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop a cervical cancer screening training program and to validate the program through the number of unsatisfactory samples and women's comfort
Basic objectives2	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	Maneuver
Interventions/Control_1	Pap smear taker training program
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	30 years-old <=
Age-upper limit	65 years-old >=
Gender	Female
Key inclusion criteria	1.Mdidwives The advanced midwives certified by CLoCMiP working for the Japanese red cross medical center or ones to be this year. 2. Women older than 30years working for the Japanese red cross medical center who come to the health center for cervical cancer screening and who give oral and written consents.
Key exclusion criteria	1.Midwives 1)not belonging to the Japanese red cross medical center. 2)Midwives not certified as advanced midwives by CLoCMiP working for the Japanese red cross medical center. 2.Among women working for the Japanese red cross medical center who receive pap smears at the health center,women 1)who do not agree to pap smears performed by trained midwives 2)in pregnancy 3)having had cervical conectomy and excluded by Ob/Gyns 4)without uterus 5)bleeding on the day as abnormal bleeding or menstration and excluded by Ob/Gyns 6)Other cases when OB/GYNs decide women should not receive a pap smear 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 Oorui machi, Takasaki city
TEL	027-352-1291
Email	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 Oorui machi, Takasaki city
TEL	027-352-1291
Homepage URL
Email	oishi-t@takasaki-u.ac.jp

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	Grant-in- Aid for scientific research by Japan Society for the Promotion of Science commintioned 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 Takasaki Univ. of Health and Welfare
Address	501 Oorui machi, Takasaki city
Tel	027-352-1291
Email	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

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 19 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	206
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	2019 Year 09 Month 20 Day
Date of IRB	2019 Year 08 Month 05 Day
Anticipated trial start date	2019 Year 11 Month 05 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 19 Day
Last modified on	2021 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043185