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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011922
Receipt No. R000013719
Scientific Title Maternal Cytomegalovirus Infection in Mie prefecture
Date of disclosure of the study information 2013/10/01
Last modified on 2019/07/25

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Basic information
Public title Maternal Cytomegalovirus Infection in Mie prefecture
Acronym Maternal Cytomegalovirus Infection in Mie prefecture
Scientific Title Maternal Cytomegalovirus Infection in Mie prefecture
Scientific Title:Acronym Maternal Cytomegalovirus Infection in Mie prefecture
Region
Japan

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

Objectives
Narrative objectives1 Detection of women who have primary infection during pregnancy
Basic objectives2 Others
Basic objectives -Others The rate of maternal primary infections during pregnancy and of newborn congenital infections
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The rate of maternal primary infections during pregnancy and of newborn congenital infections
Key secondary outcomes 1.The rate of maternal past infections before pregnancy and of newborn congenital infections
2.The rate of newborn congenital infections whose auditory screening show refer

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 Pregnant women and their newborns
Key exclusion criteria None
Target sample size 50000

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

Public contact
Name of contact person
1st name Etsuko
Middle name
Last name Kimura
Organization Mie University hospital
Division name Obstetrics and Gynecology
Zip code 514-8507
Address 2-174 Edobashi,Tsu,Mie 514-8507 Japan
TEL 059-232-1111
Homepage URL
Email sanka@clin.mie-u.ac.jp

Sponsor
Institute Mie University Hospital
Institute
Department

Funding Source
Organization None
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 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(三重県)、河合産婦人科(三重県)、鈴木レディースクリニック(三重県)、金丸産婦人科(三重県)、セントローズクリニック(三重県)、おばたレディースクリニック(三重県)、白子クリニック(三重県)、森川病院(三重県)、武田産婦人科(三重県)、南産婦人科(三重県)、玉石産婦人科(三重県)、西山産婦人科(三重県)、てらだ産婦人科(三重県)、藤本クリニック(三重県)、緑ヶ丘クリニック(三重県)、宮崎産婦人科(三重県)、三重中央医療センター、ヨナハ産婦人科小児科病院、みたき総合病院、三重レディースクリニック、済生会松阪総合病院

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 01 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 Open public recruiting
Date of protocol fixation
2013 Year 09 Month 06 Day
Date of IRB
2013 Year 09 Month 06 Day
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Comparison between the rate of newborn congenital infections whose mother has primary infection during pregnancy and the other rate of newborn congenital infections whose mother has past infection before pregnancy

Management information
Registered date
2013 Year 10 Month 01 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013719

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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