UMIN-CTR Clinical Trial

Basic information
Public title	Effect of a decision aid for birth place: A Randomized Controlled Trial for decision conflict
Acronym	Effect of a decision aid for birth place: A Randomized Controlled Trial for decision conflict
Scientific Title	Effect of a decision aid for birth place: A Randomized Controlled Trial for decision conflict
Scientific Title:Acronym	Effect of a decision aid for birth place: A Randomized Controlled Trial for decision conflict
Region	Japan

Condition
Condition	Healthy women
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effectiveness of a web-based decision aids for birth place in a randomized controlled trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Conflicts in the decision to choose the place of birth
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
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	Effect of a decision aid for birth place
Interventions/Control_2	Usual information about birth and place of birth
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	39 years-old >=
Gender	Female
Key inclusion criteria	Women who have had a vaginal birth. Married women who wish to become pregnant in the future. Women who live in Tokyo, Kanagawa, Chiba, Saitama, Osaka, and Hyogo prefectures.
Key exclusion criteria	Women who cannot understand, read and write Japanese. Women who do not have access to the internet. Medical professionals: midwives and nurses with history of perinatal work.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Sachiko Middle name Nitta Last name Nitta
Organization	University of Nagasaki
Division name	Faculty of Nursing and Nutrition
Zip code	851-2195
Address	Manabino1-1-1, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL	095-813-5470
Email	n-sachiko@sun.ac.jp

Public contact
Name of contact person	1st name Sachiko Middle name Last name Nitta
Organization	University of Nagasaki
Division name	Faculty of Nursing and Nutrition
Zip code	851-2195
Address	Manabino1-1-1, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL	095-813-5470
Homepage URL
Email	n-sachiko@sun.ac.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

Funding Source
Organization	Ministray of education, culture, sports, science and technology-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	St. Luke's International University
Address	10-1 Akashicho Chuoku Tokyo, 104-0044 Japan
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

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 31 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	476
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	2021 Year 09 Month 14 Day
Date of IRB	2021 Year 12 Month 06 Day
Anticipated trial start date	2022 Year 01 Month 06 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 12 Month 20 Day
Last modified on	2022 Year 10 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052328