The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

NCT ID: NCT01081379

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2022-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnant Women Cytomegalovirus Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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pre-conception immunity

pre-conception immunity- pregnant women with CMV seropositive

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yedidia Yifat

Yechiel Schlesinger, MD, Shaare Zedek Medical Center.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yechiel Schlesinger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yechiel Schlesinger, M.D.

Role: CONTACT

972-2-6555-147

Yifat Yedidia-Eldar, Ph. D.

Role: CONTACT

972-26666-775

Other Identifiers

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Schlesinger - CMV

Identifier Type: -

Identifier Source: org_study_id

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