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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033622
Receipt No. R000037226
Scientific Title Development and Evaluation of Birth and Parenting Planning Program for Women Who Have Been Diagnosed With Fetal Anomalies
Date of disclosure of the study information 2018/10/01
Last modified on 2019/08/04

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Basic information
Public title Development and Evaluation of Birth and Parenting Planning Program for Women Who Have Been Diagnosed With Fetal Anomalies
Acronym Development and Evaluation of Birth and Parenting Planning Program for Women Who Have Been Diagnosed With Fetal Anomalies
Scientific Title Development and Evaluation of Birth and Parenting Planning Program for Women Who Have Been Diagnosed With Fetal Anomalies
Scientific Title:Acronym Development and Evaluation of Birth and Parenting Planning Program for Women Who Have Been Diagnosed With Fetal Anomalies
Region
Japan

Condition
Condition Women who have been diagnosed with fetal anomalies
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop Birth and Parenting Planning (BPPing) program for women who have been diagnosed with fetal anomalies.
Basic objectives2 Others
Basic objectives -Others To evaluate BPPing program.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of women who submit a written preference paper called BP/BPP
Key secondary outcomes Quality data on the description of BP/BPP and questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 BPPing Program for women who have been diagnosed with fetal anomalies/Usual care
Interventions/Control_2 Intervention group has more than two meetings with team midwife in pregnancy
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 Female
Key inclusion criteria A pregnant woman who have been diagnosed with fetal anomalies, who is 20 years old or older after 22 weeks of pregnancy, who can communicate, read and write in Japanese, and to visit to a research facility as a outpatient not maternal transport.
Key exclusion criteria Women who have taken psychiatry or psychosomatic medicine.
Women who have been diagnosed with Intrauterine fetal death at fist time visiting to research facility.
Women who require hospital care in pregnancy by pregnancy complication before onset.
Women who are considered in appropriate to participate by obstetrician.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Maki
Middle name
Last name Kitazono
Organization Kanagawa Children's Medical Center
Division name Nursing Department
Zip code 2328555
Address 2-138-4 Mutukawa-Cho Minami-ku Yokohama
TEL 0457112351
Email 16dn007@slcn.ac.jp

Public contact
Name of contact person
1st name Maki
Middle name
Last name Kitazono
Organization Kanagawa Children's Medical Center
Division name Ethics Commitee in general affairs department
Zip code 2328555
Address 2-138-4 Mutukawa-Cho Minami-ku Yokohama
TEL 0457112351
Homepage URL
Email 16dn007@slcn.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

Funding Source
Organization Japan Academy of Midwife
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St.Luke's International University
Address 10-1 Akashi-cho Tyu-o-ku Tokyo
Tel 03-3543-6391
Email kenkyukikaku@luke.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 神奈川県立こども医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 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 61
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 No longer recruiting
Date of protocol fixation
2018 Year 07 Month 20 Day
Date of IRB
2018 Year 09 Month 19 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 03 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2019 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037226

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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