UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026774 |
|---|---|
| Receipt number | R000030738 |
| Scientific Title | perinatal management of maternal SSRI and SNRI use |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2019/11/18 16:11:24 |
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Basic information
Public title
perinatal management of maternal SSRI and SNRI use
Acronym
H28-NHO (Development) -02
Scientific Title
perinatal management of maternal SSRI and SNRI use
Scientific Title:Acronym
H28-NHO (Development) -02
Region
| Japan |
Condition
Condition
Anxiety disorder
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Psychiatry |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Poor neonatal adaptation of maternal SSRI, SNRI use
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
neonatal withdrawal syndrome score
Key secondary outcomes
Severe poor neonatal adaptation
PPHN
neonatal oxygen use
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 0 | days-old | <= |
Age-upper limit
| 28 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
neonates of maternal SSRI, SNRI use in third trimester of pregnancy
Key exclusion criteria
no record
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KAWADA Kou |
Organization
NHO Kyoto Medical Center
Division name
Pediatrics
Zip code
Address
Kyoto Fushimi Fukakusamukobatake 1-1
TEL
075-641-9161
kawada@kms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KAWADA Kou |
Organization
NHO Kyoto Medical Center
Division name
Pediatrics
Zip code
Address
Kyoto Fushimi Fukakusamukobatake 1-1
TEL
075-641-9161
Homepage URL
kawada@kms.ac.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
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
| 2017 | Year | 03 | Month | 31 | 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
61
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
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 09 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 09 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 18 | Day |
Other
Other related information
Finish
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2019 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030738
