UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045977 |
|---|---|
| Receipt number | R000052479 |
| Scientific Title | A target screening for congenital cytomegalovirus infection in pregnant women and newborns |
| Date of disclosure of the study information | 2021/11/04 |
| Last modified on | 2021/11/04 09:00:27 |
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Basic information
Public title
A target screening for congenital cytomegalovirus infection in pregnant women and newborns
Acronym
A target screening for congenital cytomegalovirus infection
Scientific Title
A target screening for congenital cytomegalovirus infection in pregnant women and newborns
Scientific Title:Acronym
A target screening for congenital cytomegalovirus infection
Region
| Japan |
Condition
Condition
Congenital cytomegalovirus infection
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of a new target screening for congenital cytomegalovirus infection in pregnant women and newborns.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive and negative predictive values, sensitivity and specificity of the target screening to detect congenital cytomegalovirus infection in pregnant women and newborns who have risk factors.
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
| 1 | days-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Fever or flu-like symptoms during pregnancy
2 Threatened miscarriage and threatened premature labor
3 Ultrasound abnormality associated with congenital CMV infection
4 Preterm delivery at less than 34 weeks of gestation
5 Light for date newborn
6 Automated auditory brainstem response-refer
Key exclusion criteria
Congenita anomaly, multiple pregnancy
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Yamada |
Organization
Teine Keijinkai Hospital
Division name
Center for Recurrent Pregnancy Loss
Zip code
006-8555
Address
1-40 Maeda 1-jho 12-chome Teine-ku, Sapporo 006-8555, Japan
TEL
0116818111
yamada-hideto@keijinkai.or.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Ota |
Organization
Teine Keijinkai Hospital
Division name
Obstetrics and Gynekcology
Zip code
006-8555
Address
1-40 Maeda 1-jho 12-chome Teine-ku, Sapporo 006-8555, Japan
TEL
0116818111
Homepage URL
ota-ha@keijinkai.or.jp
Sponsor or person
Institute
Teine Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teine Keijinkai Hospital, IRB
Address
1-40 Maeda 1-jho 12-chome Teine-ku, Sapporo 006-8555, Japan
Tel
0116818111
tkh-cr@keijinkai.or.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 04 | 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
| 2021 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 11 | Month | 04 | Day |
Last modified on
| 2021 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052479
