UMIN-CTR Clinical Trial

Basic information
Public title	Tests of cytomegalovirus fetomaternal infection
Acronym	Tests of cytomegalovirus fetomaternal infection
Scientific Title	Tests of cytomegalovirus fetomaternal infection
Scientific Title:Acronym	Tests of cytomegalovirus fetomaternal infection
Region	Japan

Condition
Condition	Cytomegalovirus fetomaternal infection
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We perform cytomegalovirus antibody test, viral nucleic acid test, and viral isolation test of infected mothers and congenitally infected babies.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Duration of cytomegalovus(CMV)IgM, low IgG avidity, CMV nucleic acid, and CMV isolation
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	infected mother with consent
Key exclusion criteria	congenitally infected baby from infected mother with mother's consent
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomoaki Middle name Last name Ikeda
Organization	Mie University Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	514-8507
Address	2-174 Edobashi, Tsu, Mie
TEL	059-232-1111
Email	t-kuniaki@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Kuniaki Middle name Last name Toriyabe
Organization	Mie University Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	514-8507
Address	2-174 Edobashi, Tsu, Mie
TEL	059-232-1111
Homepage URL
Email	to.kuniaki@gmail.com

Sponsor
Institute	Mie University
Institute
Department

Funding Source
Organization	Mie University
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	the Clinical Research Ethics Review Committee of the Mie University Hospital
Address	2-174 Edobashi, Tsu, Mie
Tel	059-232-1111
Email	kk-sien@mo.medic.mie-u.ac.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	三重大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 03 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	Enrolling by invitation
Date of protocol fixation	2015 Year 12 Month 03 Day
Date of IRB	2015 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 03 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design:cohort study Recruitment plan:patients matching for the criteria from December 2015 Measurement items:Cytomegalovirus(CMV)IgM, IgG avidity, CMV DNA, and CMV isolation

Management information
Registered date	2015 Year 12 Month 03 Day
Last modified on	2021 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022510