UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012607
Receipt number R000014742
Scientific Title Screening for cytomegalovirus in pregnant women
Date of disclosure of the study information 2013/12/17
Last modified on 2020/06/23 15:54:56

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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

Obstetrics 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 or person

Institute

Kobe University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014742


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name