The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection
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|ClinicalTrials.gov Identifier: NCT01081379|
Recruitment Status : Unknown
Verified February 2012 by Yedidia Yifat, Shaare Zedek Medical Center.
Recruitment status was: Not yet recruiting
First Posted : March 5, 2010
Last Update Posted : February 22, 2012
|Condition or disease|
|Maternal-fetal Transmission of Cytomegalovirus During Pregnancy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||The Relation Between the Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||August 2014|
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).
- Maternal-Fetal transmission of CMV [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081379
|Contact: Yechiel Schlesinger, M.D.||email@example.com|
|Contact: Yifat Yedidia-Eldar, Ph. D.||firstname.lastname@example.org|
|Shaare Zedek Medical Center||Not yet recruiting|
|Jerusalem, Israel, 91031|
|Principal Investigator: Yechiel Schlesinger, MD|
|Principal Investigator:||Yechiel Schlesinger, M.D.||Shaare Zedek Medical Center|