UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030044 |
|---|---|
| Receipt number | R000034308 |
| Scientific Title | A randomized controlled pilot study of a antenatal education model about cesarean section to prevent postpartum mental disorders |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2018/03/09 16:29:41 |
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Basic information
Public title
A randomized controlled pilot study of a antenatal education model about cesarean section to prevent postpartum mental disorders
Acronym
A randomized controlled trial of a antenatal education model about cesarean section
Scientific Title
A randomized controlled pilot study of a antenatal education model about cesarean section to prevent postpartum mental disorders
Scientific Title:Acronym
A randomized controlled trial of a antenatal education model about cesarean section
Region
| Japan |
Condition
Condition
postpartum mental disorders
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether there is a difference in a mental condition during hospitalization after delivery between antenatal education model about cesarean delivery for women more than 24 weeks pregnant and standard antenatal education.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
W-DEQ (Wijma Delivery Expectancy/Experience Questionnaire) version B scores which measured during hospitalization after delivery
Key secondary outcomes
1.the total score of LAS(Labour Agentry Scale)
during hospitalization after delivery
2.the total score of EPDS(Edinburgh Postnatal Depression Scale)
1 month after delivery
3.the total score of IES-R(Impact of Event Scale-Revised)
1 month after delivery
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
To give information about cesarean section during pregnancy
Interventions/Control_2
To give only standard education
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
women more than 24 weeks pregnant including nulliparous and multiparous
Key exclusion criteria
1.unmarried women under the age of 20
2.women who have a past medical history or a current medical history of mental disorder
3.women who a head nurse or the agent assess that there is a risk to have a big mental burden by participation in this study
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Furuta Marie |
Organization
Kyoto University
Division name
Graduate School of Medicine,Human Health Science,Family Nurcing Science
Zip code
Address
53, Shogoin Kawaharachou, Sakyo-ku Kyoto-shi, Kyoto, 606-8397, Japan
TEL
075-751-3972
rct.kyoto-u-mw@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ishida Aoi |
Organization
Kyoto University
Division name
Graduate School of Medicine,Human Health Science,Family Nurcing Science
Zip code
Address
53, Shogoin Kawaharachou, Sakyo-ku Kyoto-shi, Kyoto, 606-8397, Japan
TEL
075-751-3972
Homepage URL
rct.kyoto-u-mw@umin.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroo Ladies Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部付属病院（京都府）/Kyoto University Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 20 | 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
To clarify the effect of a health education about cesarean section for the improvement of perinatal mental health
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 20 | Day |
Last modified on
| 2018 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034308
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
