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The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Yedidia Yifat, Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081379
First Posted: March 5, 2010
Last Update Posted: February 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yedidia Yifat, Shaare Zedek Medical Center
  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

Resource links provided by NLM:


Further study details as provided by Yedidia Yifat, Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Maternal-Fetal transmission of CMV [ Time Frame: 1 year ]

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
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).

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with primary CMV
Criteria

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
Information from the National Library of Medicine

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


Contacts
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

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Principal Investigator: Yechiel Schlesinger, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Yechiel Schlesinger, M.D. Shaare Zedek Medical Center
  More Information

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
First Submitted: March 4, 2010
First Posted: March 5, 2010
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Yedidia Yifat, Shaare Zedek Medical Center:
Cytomegalovirus Infections
Pregnancy
T-Lymphocytes
Transmission

Additional relevant MeSH terms:
Infection