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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034384
Receipt No. R000039178
Scientific Title The association of folic acid intake during pregnancy with maternal mental state and perinatal outcome
Date of disclosure of the study information 2018/10/10
Last modified on 2018/10/04

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Basic information
Public title The association of folic acid intake during pregnancy with maternal mental state and perinatal outcome
Acronym Folic acid pilot study
Scientific Title The association of folic acid intake during pregnancy with maternal mental state and perinatal outcome
Scientific Title:Acronym Folic acid pilot study
Region
Japan

Condition
Condition pregnant and parturient women
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the prevalence of perinatal depression
Basic objectives2 Others
Basic objectives -Others To investigate the association folic acid intake during pregnancy with perinatal depression
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the Center for Epidemiologic Studies Depression Scale, the Japanese version of the Edinburgh Postnatal Depression Scale and serum biomarkers
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 the Center for Epidemiologic Studies Depression Scale
The Japanese version of the Edinburgh Postnatal Depression Scale
Interventions/Control_2
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
20 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria Participants were singleton pregnancies who had been followed up at our hospital
Key exclusion criteria twin pregnancy, under the age of 20, change the hospital at delivery
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Misao Nakanishi
Organization National Center for Global Health and Medicine
Division name Division of Obstetrics and Gynecology
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL +81-03-3202-7181
Email mnakanishi@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Misao Nakanishi
Organization National Center for Global Health and Medicine
Division name Department of obstetrics and gynecology
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL +81-03-3202-7181
Homepage URL
Email mnakanishi@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 10 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 04 Day
Last modified on
2018 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039178

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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