UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057990 |
|---|---|
| Receipt number | R000066296 |
| Scientific Title | An Interventional Study to Evaluate the Effectiveness of Family Planning Guidance for Couples |
| Date of disclosure of the study information | 2025/05/27 |
| Last modified on | 2025/11/26 09:04:23 |
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Basic information
Public title
A Study Examining the Effectiveness of Family Planning Guidance for Couples
Acronym
A Study of Family Planning
Scientific Title
An Interventional Study to Evaluate the Effectiveness of Family Planning Guidance for Couples
Scientific Title:Acronym
Family Planning Intervention Study
Region
| Japan |
Condition
Condition
postpartum women and their partners
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Are women who received family planning counseling as a couple more likely to implement their desired family planning method compared to those who received conventional counseling?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The desired family planning method at six months postpartum
Key secondary outcomes
Marital Relationship Satisfaction Scale
WHO QOL26
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Provide a 60-minute family planning counseling session
Interventions/Control_2
control
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Age 18 years or older at the time of consent
Women who have a husband (partner)
Patients who consented to participate in this study
Key exclusion criteria
Participants scheduled to undergo tubal ligation or hysterectomy during the current childbirth
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | sanae |
| Middle name | |
| Last name | yamaguchi |
Organization
Fukushima Medical University
Division name
School of Nursing
Zip code
960-1295
Address
9601295
TEL
0245471853
sayama@fmu.ac.jp
Public contact
Name of contact person
| 1st name | sanae |
| Middle name | |
| Last name | yamaguchi |
Organization
Department of Maternal Nursing and Midwifery
Division name
School of Nursing
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima
TEL
0245471853
Homepage URL
sayama@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
sanae yamaguchi
Funding Source
Organization
Japan society for the promotion science
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
Department of Maternal Nursing and Midwifery
Address
1 Hikarigaoka, Fukushima City, Fukushima
Tel
0245471853
sayama@fmu.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
| 2025 | Year | 05 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 07 | 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
| 2025 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066296
