UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053698 |
|---|---|
| Receipt number | R000061279 |
| Scientific Title | Effectiveness of Hybrid Online Antenatal Child-rearing Education & Postpartum Parenting Support for Primiparous Couples' Well-being: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/03/04 |
| Last modified on | 2024/03/08 15:59:43 |
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Basic information
Public title
Effectiveness of Hybrid Online Antenatal Child-rearing Education & Postpartum Parenting Support for First-time Expectant Parents
Acronym
Effectiveness of Hybrid Online Antenatal Child-rearing Education & Postnatal Parenting Support for First-time Expectant Parents
Scientific Title
Effectiveness of Hybrid Online Antenatal Child-rearing Education & Postpartum Parenting Support for Primiparous Couples' Well-being: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of Hybrid Online Antenatal Child-rearing Education & Postpartum Parenting Support for 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 effects of hybrid online prenatal education and postnatal childcare support for primiparous mothers and their husbands on 1) child-rearing readiness & child-rearing self-efficacy, 2) marital relationship satisfaction & co-parenting, 3) depressive symptoms, 4) maternal role confidence & satisfaction, 5) parenting stress, and 6) breastfeeding satisfaction.
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) Postnatal depressive symptoms, 3) Maternal role confidence and satisfaction, and 4) Co-parenting
Key secondary outcomes
1) marital relationship satisfaction, 2) parenting stress, and 3) breastfeeding satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
On-demand distribution of video teaching materials and guidebooks on postpartum parenting for primiparous couples
Interventions/Control_2
Live-online antenatal parenting counseling,
Live-online postnatal parenting counseling
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A primiparous woman and her husband/partner
2) A singleton pregnancy
3) 22 to 30 weeks pregnant
4) No diseases that require treatment during pregnancy
Key exclusion criteria
1) A woman or her husband/partner who has difficulty communicating in Japanese
2) Preterm birth, neonatal death
3) Persons with serious diseases in the fetus or newborn
4) If the mother or husband/partner has a serious illness and is unable to raise the child due to hospitalization, etc
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Emi |
| Middle name | |
| Last name | Mori |
Organization
Chiba University Graduate School of Nursing
Division name
Division of Innovative Nursing for Life Course
Zip code
260-8672
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
+81-43-226-2410
mori@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Mori |
Organization
Chiba University Graduate School of Nursing
Division name
Division of Innovative Nursing for Life Course,Reproductive Health Nursing, MAMAtasu Research Office
Zip code
2608672
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
repron-aer@chiba-u.jp
Sponsor or person
Institute
Department of Health Promotion in Nursing and Midwifery,
Division of Innovative Nursing for Life Course,
Institute
Department
Personal name
Emi Mori
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee at Graduate School of Nursing, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
+81-43-226-2133
kango-rinri@chiba-u.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
総合母子保健センター附属愛育病院（東京都）、山口病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 04 | 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
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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061279
| 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 |
