UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046270 |
|---|---|
| Receipt number | R000052801 |
| Scientific Title | Development of Prenatal Couple Education Program Emphasizing on Co-parenting for Iranian Couples |
| Date of disclosure of the study information | 2021/12/03 |
| Last modified on | 2023/06/05 09:11:43 |
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Basic information
Public title
Development of Prenatal Couple Education Program Emphasizing on Co-parenting for Iranian Couples
Acronym
Co-parenting program for Iranian Couples
Scientific Title
Development of Prenatal Couple Education Program Emphasizing on Co-parenting for Iranian Couples
Scientific Title:Acronym
Co-parenting program for Iranian Couples
Region
| Asia(except Japan) |
Condition
Condition
pregnancy
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of Prenatal Couple Education Program Emphasizing on Co-parenting for Iranian Couples
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
coparenting relationship
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
coparenting promote program
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)a couple who will have their first child
(2) Those who can read and write Farsi.
(3) A couple lives together.
(4) Have an Internet connection such as a smartphone or PC (necessary for registration and questionnaire responses and attend at classes).
Key exclusion criteria
(1) Not living with a couple or children at the time of recruitment
(2) Those who are unable to read and write Farsi.
(3) Same-sex couples
(4) Other cases in which the researcher deems participation in the study to be inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Toyoko |
| Middle name | |
| Last name | YOSHIZAWA |
Organization
Tohoku University,Graduate School of Medicine
Division name
Women's health nursing & midwifery
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku,sendai
TEL
+81227177915
toyoko@nursing.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuka |
| Middle name | |
| Last name | NAKAMURA |
Organization
Tohoku University,Graduate School of Medicine
Division name
Women's health nursing & midwifery
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku,sendai
TEL
+81227177957
Homepage URL
ynaka@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate school of Med
Address
2-1,Seiryomachi, aobaku, sendai
Tel
022-717-7957
ynaka@tohoku.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 | 03 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052801
