UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002124 |
|---|---|
| Receipt number | R000002591 |
| Scientific Title | Screening of cyromegalovirus infection in pregnant women and prevention of congenital cytomegalovirus infection of fetuses |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2009/06/26 14:57:52 |
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Basic information
Public title
Screening of cyromegalovirus infection in pregnant women and prevention of congenital cytomegalovirus infection of fetuses
Acronym
cyromegalovirus infection in pregnant women and prevention of congenital cytomegalovirus infection
Scientific Title
Screening of cyromegalovirus infection in pregnant women and prevention of congenital cytomegalovirus infection of fetuses
Scientific Title:Acronym
cyromegalovirus infection in pregnant women and prevention of congenital cytomegalovirus infection
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
prevention of CCMVI newborns from pregnant women with CMV by administration of IgG
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevention of CCMVI newborns
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Gene |
Interventions/Control_1
administration of IgG to pregnant women infected with CMV
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
Female
Key inclusion criteria
pregnant women
Key exclusion criteria
pregnant women not infected with CMV
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mayumi morizane |
Organization
Kobe University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
7-5-1 Kusunoki-Cho Chuo-Ku, Kobe, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi morizane |
Organization
Kobe University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
no fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 26 | Day |
Last modified on
| 2009 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002591
