UMIN-CTR Clinical Trial

Basic information
Public title	Screening for cytomegalovirus in pregnant women
Acronym	Screening for cytomegalovirus in pregnant women
Scientific Title	Screening for cytomegalovirus in pregnant women
Scientific Title:Acronym	Screening for cytomegalovirus in pregnant women
Region	Japan

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

Objectives
Narrative objectives1	To determine the efficacy of blood screening to identify the infants with congenital CMV infection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To identify the infants with congenital CMV infection
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	18 years-old <
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Pregnant women
Key exclusion criteria	N/A
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideto Yamada
Organization	Kobe University Hospital
Division name	Obstetrics and Gynecology
Zip code
Address	7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL	078-382-6000
Email	yhideto@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ichiro Morioka
Organization	Kobe University Hospital
Division name	Pediatrics
Zip code
Address	7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL	078-382-6090
Homepage URL
Email	ichim@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Grants-in-Aid from the Ministry of Health, Labor and Welfare of Japan
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
Email

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	2013 Year 12 Month 17 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	Completed
Date of protocol fixation	2011 Year 04 Month 01 Day
Date of IRB	2010 Year 11 Month 19 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	At 16 to 18 weeks of gestations, enrolled pregnant women are measured CMV-IgG and IgG Avidity Index in their blood. If the pregnant women have negative results of CMV IgG, they are remeasure CMV IgG at 35 weeks of gestations.

Management information
Registered date	2013 Year 12 Month 17 Day
Last modified on	2020 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014742