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NCT01081379 Clinical Trial

The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

Cytomegalovirus Infections Clinical Trial

Official title:
The Relation Between the Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01081379
Other study ID # Schlesinger - CMV
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2014
Est. completion date August 2022

Study information
Verified date November 2019
Source Shaare Zedek Medical Center
Contact Yechiel Schlesinger, M.D.
Phone 972-2-6555-147
Email s.yechiel@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission.

Description:

Fetal infection with CMV is the most common cause of intrauterine infection. Only 40% of pregnant women with primary CMV transmit the virus to their fetus. Many of these women are referred to amniocentesis and many elect to terminate pregnancy without knowledge about fetal infection or damage. Currently it is assumed that transmission is dictated by variety of factors including maternal and fetal immune system. Efforts to find correlation between maternal immune system and fetal infection which can be used as a diagnostic marker were unsuccessful.

Our hypothesis is that there is a correlation between cellular immune response of the mother to CMV infection and viral transmission to the fetus.

Pregnant women with primary CMV infection (40% of whom are expected to be transmitters)and with pre-conception immunity will participate in this study.

Blood from these women will be incubated with CMV peptides and T cell activation will be measured by the secretion of various cytokines.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 2022
Est. primary completion date August 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Pregnant women

- CMV IgG sero-conversion or the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies.

Exclusion Criteria:

- Underlying immune deficiencies

- Other pregnancy complications

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Shaare Zedek Medical Center Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maternal-Fetal transmission of CMV 1 year
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