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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 January 2018
Main ID:  NCT02129465
Date of registration: 27/04/2014
Prospective Registration: Yes
Primary sponsor: Shaare Zedek Medical Center
Public title: Immunological Characteristics of Maternal-fetal Transmission of Cytomegalovirus in Pregnancy CMV
Scientific title: Correlates of Maternal Characteristics in CMV Infection in Pregnancy With Maternal-fetal Transmission.
Date of first enrolment: June 2014
Target sample size: 100
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02129465
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Israel
Contacts
Name:     Yifat Eldar-Yedidia, Ph.D.
Address: 
Telephone: 972-54-6878093
Email: yifat4@gmail.com
Affiliation: 
Name:     Yechiel Schlesinger, MD
Address: 
Telephone: 972-2-6555-197
Email: s.yechiel@gmail.com
Affiliation: 
Name:     Yechiel Schlesinger, MD
Address: 
Telephone:
Email:
Affiliation:  Shaare Zedek Medical Center, Jerusalem, Israel
Name:     Yifat Eldar-Yedidia, Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Shaare Zedek Medical Center, Jerusalem, Israel
Key inclusion & exclusion criteria

Inclusion Criteria:

- pregnant women

- CMV infection: primary infection: (1) CMV-specific IgG seroconversion or (2)
demonstration of low avidity CMV-specific IgG antibodies, (3) the primary appearance
of CMV-specific IgM with no previous IgG, and (4) CMV DNA or viral products in blood
Secondary infection: appearance of CMV-specific IgM with positive IgG

Exclusion Criteria:

- CMV status unclear

- spontaneous or induced abortion

- unknown fetal outcome



Age minimum: 18 Years
Age maximum: 42 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Pregnancy
Congenital Infection
Cytomegalovirus Infections
Intervention(s)
Primary Outcome(s)
Maternal-fetal transmission of CMV [Time Frame: up to 2 years]
Secondary Outcome(s)
Symptomatic congenital CMV [Time Frame: up to 2 years]
Secondary ID(s)
CMV_transmission.CTIL
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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