UMIN-CTR Clinical Trial

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	Obsterics 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
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 Nakaoorui Takasaki city
TEL	027352-1291
Homepage URL
Email	oishi-t@takasaki-u.ac.jp

Sponsor
Institute	National Defense Medical College Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038753