UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled pilot study of a antenatal education model about cesarean section to prevent postpartum mental disorders
Title of the study (Brief title)	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	Furuta Marie
Organization	Kyoto University
Division name	Graduate School of Medicine,Human Health Science,Family Nurcing Science
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	Ishida Aoi
Organization	Kyoto University
Division name	Graduate School of Medicine,Human Health Science,Family Nurcing Science
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	To clarify the effect of a health education about cesarean section for the improvement of perinatal mental health
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