UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021475 |
|---|---|
| Receipt number | R000024712 |
| Scientific Title | Study protocol for a randomized controlled trial of the effectiveness providing information on childbirth and postnatal period to partners of pregnant women |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2021/03/25 14:46:09 |
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Basic information
Public title
Study protocol for a randomized controlled trial of the effectiveness providing information on childbirth and postnatal period to partners of pregnant women
Acronym
Study to evaluate the effectiveness of providing information to partners of pregnant women
Scientific Title
Study protocol for a randomized controlled trial of the effectiveness providing information on childbirth and postnatal period to partners of pregnant women
Scientific Title:Acronym
Study to evaluate the effectiveness of providing information to partners of pregnant women
Region
| Japan |
Condition
Condition
Paternal depression
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the distribution of a booklet providing information to fathers during their partners' pregnancies on fathers' and mothers' postpartum mental health and quality of life, as well as on fathers' childcare participation and living situations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of paternal depression at either one month or three months (Paternal depression is defined as an EPDS score of 8 and above).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
the subjects in the intervention group will be sent a booklet containing information for fathers on pregnancy, childbirth, and childcare. This booklet consists of 32 B5 pages including information on topics including matters such as what preparations the partner should make before the birth and tips for housework and childcare as well as how to prevent unintentional injury to the baby.
Interventions/Control_2
No intervention for the subjects in control group
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
Pregnant women due to give birth at a obstetric clinic in the Aichi Prefecture, Japan and their partners
Key exclusion criteria
(1) Women who underwent their first prenatal health checkup later than 28 weeks gestation
(2) One or both members of the couple is unable to read or write Japanese
(3) Individuals undergoing special medical treatment or care for existing mental health problems or poor health due to serious obstetric complications
(4) those judged by an investigator to be unsuitable to participate in the study for any other reason.
Target sample size
554
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Takehara |
Organization
National Center for Child Health and Development
Division name
Department of Health Pocily
Zip code
157-8535
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
03-3416-0181
takehara-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Takehara |
Organization
National Center for Child Health and Development
Division name
Department of Health Pocily
Zip code
157-8535
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
03-3416-0181
Homepage URL
takehara-k@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Young Scientists (B)
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 National Center for Child Health & Development
Address
10-1, Okura 2chome, Setagaya, Tokyo, JAPAN
Tel
03-3416-0181(5927)
rinri@ncchd.go.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
岡村産科婦人科（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/6/7/e011919.long
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
577
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Under review
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 15 | Day |
Last modified on
| 2021 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024712
