UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023935 |
|---|---|
| Receipt number | R000027406 |
| Scientific Title | Analysis of state-trait anxiety in clients of non-invasive prenatal testing; an investigation to improve the quality of genetic counseling |
| Date of disclosure of the study information | 2016/09/10 |
| Last modified on | 2017/11/02 17:49:49 |
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Basic information
Public title
Analysis of state-trait anxiety in clients of non-invasive prenatal testing; an investigation to improve the quality of genetic counseling
Acronym
Analysis of state-trait anxiety in clients of non-invasive prenatal testing; an investigation to improve the quality of genetic counseling
Scientific Title
Analysis of state-trait anxiety in clients of non-invasive prenatal testing; an investigation to improve the quality of genetic counseling
Scientific Title:Acronym
Analysis of state-trait anxiety in clients of non-invasive prenatal testing; an investigation to improve the quality of genetic counseling
Region
| Japan |
Condition
Condition
late childbearing
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether a prior counseling to non-invasive prenatal testing reliefs the anxiety level in the pregnant women who undergo the testing using State-Trait Anxiety Inventory.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Difference in the score of state anxiety between the group A clients who undergo NIPT just after explanation on the testing and the group B clients who have preliminary counseling one to two weeks prior to NIPT.
Key secondary outcomes
To evaluate the reliability and appropriateness of questions except for NIPT in the questionnaire that will be used in Phase III study.
How many percentage of couples do discuss each other about NIPT?
The number of clients that cancel non-invasive prenatal testing.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The group A clients who undergo NIPT just
after genetic counseling
Interventions/Control_2
The group B clients who have preliminary
counseling one or two weeks prior to NIPT
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
| 34 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Clients who undergo NIPT at Niigata University Hospital due to late childbearing.
Clients who can wait for more than 2 weeks prior to NIPT.
Key exclusion criteria
Clients who undergo NIPT due to some reason
other than late childbearing.
Clients who reside outside of Niigata Prefecture.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi Takakuwa |
Organization
Niigata University Hospital
Division name
General Center for Perinatal,Maternal and Neonatal Medicine
Zip code
Address
1-754 Asahimachi,Niigata City,Niigata,Japan
TEL
025-223-6161
sao420.416.81.87@bloom.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saori Fujita |
Organization
Niigata University Hospital
Division name
Maternity ward,Maternal Fetal Int ensive Care Unit
Zip code
Address
1-754 Asahimachi,Niigata City,Niigata,Japan
TEL
025-227-2632
Homepage URL
sao420.416.81.87@bloom.ocn.ne.jp
Sponsor or person
Institute
Niigata university Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 06 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 05 | Day |
Last modified on
| 2017 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027406
| 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 |
