UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of state-trait anxiety in clients of non-invasive prenatal testing; an investigation to improve the quality of genetic counseling
Title of the study (Brief title)	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	Obsterics 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	Kouichi Takakuwa
Organization	Niigata University Hospital
Division name	General Center for Perinatal,Maternal and Neonatal Medicine
Address	1-754 Asahimachi,Niigata City,Niigata,Japan
TEL	025-223-6161
Email	sao420.416.81.87@bloom.ocn.ne.jp

Public contact
Name of contact person	Saori Fujita
Organization	Niigata University Hospital
Division name	Maternity ward,Maternal Fetal Int ensive Care Unit
Address	1-754 Asahimachi,Niigata City,Niigata,Japan
TEL	025-227-2632
Homepage URL
Email	sao420.416.81.87@bloom.ocn.ne.jp

Sponsor
Institute	Niigata university Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027406