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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030044
Receipt No. 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

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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
Email 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
Email rct.kyoto-u-mw@umin.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034308

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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