UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047561 |
|---|---|
| Receipt number | R000054238 |
| Scientific Title | Randomized trial with educational intervention using brochures about preconception care |
| Date of disclosure of the study information | 2022/04/25 |
| Last modified on | 2024/04/24 07:37:11 |
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Basic information
Public title
Randomized trial with educational intervention using brochures about preconception care
Acronym
Randomized trial with educational intervention using brochures about preconception care
Scientific Title
Randomized trial with educational intervention using brochures about preconception care
Scientific Title:Acronym
Randomized trial with educational intervention using brochures about preconception care
Region
| Japan |
Condition
Condition
Any psychiatry disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the usefulness of a pamphlet and a brief educational intervention for preconception care in women of childbearing age attending psychiatry.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavior changes of patient in hospital
Key secondary outcomes
1)knowledge of preconception care 2)alienation factor of behavior change 3) behavior changes of patient at home 4) Whether or not patients have been privided with information about pregnancy and psychotropic medication.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Provide information using booklets and survey behavior changes and knowledge of preconception care after 8 weeks
Interventions/Control_2
Provide treatment as usual and survey behavior changes and knowledge of preconception care after 8 weeks
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients who regularly see a doctor in Chiba University Hospital, IUHW Narita hospital, Sodegaura Satsukidai Hospital.
2. Any psychiatric depressive disorder by DSM-5
3. Patients with 18-40 years of age at study entry
4. Patients with fertility.
5.Written informed consent by patients
Key exclusion criteria
1.Pregnant women at study entry
2.Patients who have been sexually assaulted, have gender dysphoria.
3.Patients at risk of suicide attempts
4.Patients who are otherwise deemed by the attending physician or principal investigator or sub investigator to be unsuitable for the safe conduct of this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masaomi |
| Middle name | |
| Last name | Iyo |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Hashimoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
t-hashimoto@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Government
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
IUHW narita hospital, Sodegaura Satsukidai hosapital, Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of the graduate school of medicine, Chiba university
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel
043-222-7171
inohana-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
千葉大学医学部附属病院(千葉県）、袖ケ浦さつき台病院(千葉県)、国際医療福祉大学成田病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 25 | 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
| 2022 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2022 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054238
