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The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Yedidia Yifat, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01081379
First received: March 4, 2010
Last updated: February 20, 2012
Last verified: February 2012

March 4, 2010
February 20, 2012
February 2012
February 2014   (final data collection date for primary outcome measure)
Maternal-Fetal transmission of CMV [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01081379 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection
The Relation Between the Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

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

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

serum

Non-Probability Sample

Pregnant women with primary CMV

Maternal-fetal Transmission of Cytomegalovirus During Pregnancy
Not Provided
  • pre-conception immunity
    pre-conception immunity- pregnant women with CMV seropositive
  • primary CMV infection
    primary CMV infection- pregnant women with primary CMV infection (defined as CMV IgG sero-conversion, the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
August 2014
February 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact: Yechiel Schlesinger, M.D. 972-2-6555-147 s.yechiel@gmail.com
Contact: Yifat Yedidia-Eldar, Ph. D. 972-26666-775 yifat4@gmail.com
Israel
 
NCT01081379
Schlesinger - CMV
No
Yedidia Yifat, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Yechiel Schlesinger, M.D. Shaare Zedek Medical Center
Shaare Zedek Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP