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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038753


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name