The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection
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Purpose
The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission.
| Condition |
|---|
|
Maternal-fetal Transmission of Cytomegalovirus During Pregnancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | The Relation Between the Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection |
- Maternal-Fetal transmission of CMV [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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pre-conception immunity
pre-conception immunity- pregnant women with CMV seropositive
|
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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).
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pregnant women with primary CMV
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
Contacts and Locations| 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 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Yedidia Yifat, Yechiel Schlesinger, MD, Shaare Zedek Medical Center., Shaare Zedek Medical Center |
| ClinicalTrials.gov Identifier: | NCT01081379 History of Changes |
| Other Study ID Numbers: | Schlesinger - CMV |
| Study First Received: | March 4, 2010 |
| Last Updated: | February 20, 2012 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Shaare Zedek Medical Center:
|
Cytomegalovirus Infections Pregnancy T-Lymphocytes Transmission |
ClinicalTrials.gov processed this record on May 19, 2013