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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009338
Receipt No. R000010966
Scientific Title Evaluation of genetic counceling in the noninvasive prenatal genetic testing
Date of disclosure of the study information 2012/11/15
Last modified on 2017/05/21

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Basic information
Public title Evaluation of genetic counceling in the noninvasive prenatal genetic testing
Acronym NIPT study
Scientific Title Evaluation of genetic counceling in the noninvasive prenatal genetic testing
Scientific Title:Acronym NIPT study
Region
Japan

Condition
Condition pregnant women at risk for fetal aneuploidy
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the quality of the genetic counceling
Basic objectives2 Others
Basic objectives -Others Evaluate the current status
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes level of understandings on the genetic councelings
Key secondary outcomes

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
20 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria 1. over 35 years old at the time of delivery
2. previous history of birth of baby with aneuploidy
3. pregnant women at risk for fetal aneuploidy screened out by serum test or ultrasound test
Key exclusion criteria Not desire the test
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Sago
Organization National center for Child-health and development
Division name Perinatal Center
Zip code
Address 2-10-1Ookura, Setagaya-ku, Tokyo
TEL 03-3416-0181
Email sagou-h@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Sekizawa
Organization Showa Univ.
Division name ObGyn
Zip code
Address 1-5-8 Hatanodai Shinagawa
TEL 03-3784-8000
Homepage URL
Email sekizawa@med.showa-u.ac.jp

Sponsor
Institute NIPT consortium
Institute
Department

Funding Source
Organization Non
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Of 7,740 women tested, 142 (1.8%) had positive results, 7,594 (98.1%) had negative results, and 4 (0.1%) had results that were not reportable. Of the 142 women who tested positive, 13 cases resulted in intrauterine fetal death, 3 cases refused to confirm by invasive procedure. Of the 126 positive cases confirmed karyotyping, normal karyotype cases were 3 for trisomy 21, 8 for trisomy 18, and 2 for trisomy 13. In the follow-up study of negative cases (n=1,638), one false negative case of trisomy 18 was observed.
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
2012 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 31 Day
Last follow-up date
2015 Year 02 Month 28 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information not started

Management information
Registered date
2012 Year 11 Month 15 Day
Last modified on
2017 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010966

Research Plan
Registered date File name
2017/05/21 Report.docx

Research case data specifications
Registered date File name
2017/05/21 Report.docx

Research case data
Registered date File name
2017/05/21 Report.docx


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