The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection
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| First Received Date ICMJE | March 4, 2010 | ||||||||
| Last Updated Date | February 20, 2012 | ||||||||
| Start Date ICMJE | February 2012 | ||||||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Maternal-Fetal transmission of CMV [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01081379 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection | ||||||||
| Official Title ICMJE | The Relation Between the Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection | ||||||||
| Brief Summary | The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: serum |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Pregnant women with primary CMV |
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| Condition ICMJE | Maternal-fetal Transmission of Cytomegalovirus During Pregnancy | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | August 2014 | ||||||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01081379 | ||||||||
| Other Study ID Numbers ICMJE | Schlesinger - CMV | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Yedidia Yifat, Shaare Zedek Medical Center | ||||||||
| Study Sponsor ICMJE | Shaare Zedek Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Shaare Zedek Medical Center | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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