UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037226