UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033622 |
|---|---|
| Receipt number | 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 | 2022/02/14 21:48:07 |
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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
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
16dn007@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
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
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
Not yet officially announced
Publication of results
Unpublished
Result
URL related to results and publications
https://luke.repo.nii.ac.jp/?action=pages_view_main&active_action=repository_view_main_item_detail&i
Number of participants that the trial has enrolled
61
Results
The intervention group had a significantly higher rate submitting BP/BPP (96.0%vs.7.1%, p<0.001) and significantly higher SRESP (t=3.210, p=0.003). The intervention group tended to have higher but non-significant Satisfaction of Care scores. The J-SSQ had no significant differences between the two groups. Women's preferences were both similar and unique. The intervention group had more positive statements (BP/BPP) about their experience.
Results date posted
| 2022 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age: 33.5 years old
The baby's fetal diagnosis: congenital heart disease (n=18), craniofacial disease (n=9), neural tube defects (n=4), congenital diaphragmatic hernias (n=4),chromosomal abnormalities (n=3), Gastrointestinal closure (n=3), and others (n=10).
Participant flow
Sixty-two women (32 in the intervention group, 30 in the control group) were enrolled, 11 women were dropped out during the intervention period (7 in the intervention group; 21.9%, 4 in the control group; 13.3%). Fifty-five women were analyzed.
Adverse events
There was no adverse event.
Outcome measures
Primary outcome
The rate submitting BP/BPP
Secondary outcome
1)Quantitative data
The Score of Women's perception of being able to express and sharing of hopes scale
The Score of Social support scale
The Score of Women's Care Satisfaction Scale and VAS for satisfaction
2)Qualitative data
The contents described women's BP/BPP
Descriptions of Women's perception of being able to express and sharing of hopes
Descriptions women's perception of care
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 03 | Day |
Last modified on
| 2022 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037226
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
