UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034384 |
|---|---|
| Receipt number | 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 | 2023/04/10 14:59:59 |
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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
| Obstetrics 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 | Misao |
| Middle name | |
| Last name | Nakanishi |
Organization
National Center for Global Health and Medicine
Division name
Division of Obstetrics and Gynecology
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
+81-03-3202-7181
mnakanishi@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Misao |
| Middle name | |
| Last name | Nakanishi |
Organization
National Center for Global Health and Medicine
Division name
Department of obstetrics and gynecology
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
+81-03-3202-7181
Homepage URL
mnakanishi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
National Center for Global Health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel
03-3202-7181
rinrijim@hosp.ncgm.go.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
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
Terminated
Date of protocol fixation
| 2018 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
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
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039178
| Research Plan | |
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| 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 |
