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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035397
Receipt No. R000040331
Scientific Title Effectiveness of antenatal child-rearing education and infant bathing education on postpartum well-being specifically developed for older primiparous couples: A randomized controlled trial
Date of disclosure of the study information 2019/01/01
Last modified on 2018/12/28

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Basic information
Public title Effectiveness of antenatal child-rearing education and infant bathing education on postpartum well-being specifically developed for older primiparous couples: A randomized controlled trial
Acronym Effectiveness of antenatal child-rearing education and infant bathing education specifically developed for older primiparous couples
Scientific Title Effectiveness of antenatal child-rearing education and infant bathing education on postpartum well-being specifically developed for older primiparous couples: A randomized controlled trial
Scientific Title:Acronym Effectiveness of antenatal child-rearing education and infant bathing education specifically developed for older primiparous couples
Region
Japan

Condition
Condition No disease
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of a newly developed antenatal parenting education program using a randomized controlled trial for older primiparous couples before childbirth and at 1 and 4 months postpartum based on 1) preparedness and self-efficacy toward child-rearing, 2) fatigue, 3) postnatal depressive symptoms, 4) maternal role confidence and satisfaction, and 5) co-parenting
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Preparedness and self-efficacy toward child-rearing, 2) fatigue, 3) postnatal depressive symptoms, 4) maternal role confidence and satisfaction, and 5) co-parenting
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 E-learning educational material about child-rearing and a prenatal guidebook for older primiparous couples
Interventions/Control_2 E-learning educational material about infant bathing
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
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)A pregnant Japanese woman scheduled to give birth at a participating facility
2)A primiparous woman aged 35 or older and her husband/partner
3)A singleton pregnancy
4)A woman in a marital relationship (including common-law marriage)
5)A woman not raising any child (including an adopted child or child by previous marriage)
6)A woman whose address is definite during the first four months postpartum
Key exclusion criteria 1)A woman who has difficulty communicating in Japanese
2)A woman who conceived with a donor egg or semen (e.g., artificial insemination with donor semen, pregnancy with donor egg in procedure outside Japan)
3)Severe diseases (including psychological disorders) in pregnant woman, fetus, or husband/partner (persons who cannot endure this study)
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Emi Mori
Organization Chiba University Graduate School of Nursing
Division name Reproductive Health Nursing
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL +81-43-226-2410
Email mori@faculty.chiba-u.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Emi Mori
Organization Chiba University Graduate School of Nursing
Division name Reproductive Health Nursing, MAMAtasu Research Office
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL +81-43-226-2413
Homepage URL http://www.n.chiba-u.jp/mamatasu/index.html
Email ReproN-AER@chiba-u.jp

Sponsor
Institute MEXT(Japan)
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 千葉メディカルセンター(千葉県)/Chiba Medical Center (Chiba)
医療法人 葵鐘会 (愛知県)/Medical Corporation Kishokai (Aichi)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 01 Day

Related information
URL releasing protocol http://www.n.chiba-u.jp/mamatasu/index.html
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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 07 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
2020 Year 07 Month 31 Day
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 12 Month 28 Day
Last modified on
2018 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040331

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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