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The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

S

Shaare Zedek Medical Center

Status

Unknown

Conditions

Pregnant Women
Cytomegalovirus Infections

Study type

Observational

Funder types

Other

Identifiers

NCT01081379
Schlesinger - CMV

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

pre-conception immunity
Description:
pre-conception immunity- pregnant women with CMV seropositive
primary CMV infection
Description:
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).

Trial contacts and locations

1

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Central trial contact

Yechiel Schlesinger, M.D.; Yifat Yedidia-Eldar, Ph. D.

Data sourced from clinicaltrials.gov

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