UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035397 |
|---|---|
| Receipt number | 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 | 2023/07/13 13:21:02 |
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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
Name of lead principal investigator
| 1st name | Emi |
| Middle name | |
| Last name | Mori |
Organization
Chiba University Graduate School of Nursing
Division name
Reproductive Health Nursing
Zip code
260-6672
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
Reproductive Health Nursing, MAMAtasu Research Office
Zip code
260-8672
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
MEXT(Japan)
Institute
Department
Personal name
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
Ethics Committee at Graduate School of Nursing, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
+81-43-226-2380
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
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)
東京歯科大学市川総合病院（千葉県）/Tokyo Dental College Ichikawa General Hospital (Chiba)
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
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-17H01612/
Number of participants that the trial has enrolled
283
Results
Participants in the intervention group were significantly more likely than those in the control group to report that they were able to imagine postpartum life with their baby. The expectant fathers in the intervention group showed improved Parenting Self-Efficacy scores after the intervention compared with the control group. However, expectant mothers exhibited no significant differences among the two groups.
Results date posted
| 2023 | Year | 01 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The reason for the delay is that data collection was delayed due to the fact that the number of research participants was not gathered due to the influence of COVID-19. We will present the main result, taitled"Effectiveness of Online Antenatal Education Program for Older Primiparous Couples on Parenting Readiness: A Randomized Controlled Trial" at the 26th East Asian Forum of Nursing Scholars on March 2023.
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 11 | Day |
Baseline Characteristics
The mean age of pregnant women was 38.0 (SD = 2.5) years. The baseline data were not significantly different between groups.
Participant flow
1.Research participant registration with consent to participate in this research, 2.Random allocation to 2 groups (intervention group: A, control group: B), 3.Pre-intervention (pre-e-Learning) questionnaire reply, 4.Group decision notification, e-Learning materials and URL & password, 5.e-Learning, 6.Questionnaire survey after prenatal intervention, 7.Questionnaire survey one month after childbirth, 8.Questionnaire survey four months after childbirth
Adverse events
None
Outcome measures
1) Preparedness and self-efficacy toward child-rearing, 2) fatigue, 3) postnatal depressive symptoms, 4) maternal role confidence and satisfaction, and 5) co-parenting
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040331
