Clinical trial NCT02129465: Immunological Characteristics of Maternal-fetal Transmission of Cytomegalovirus in Pregnancy
Official title: Correlates of Maternal Characteristics in CMV Infection in Pregnancy With Maternal-fetal Transmission.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Cytomegalovirus Infections
Congenital Infection
Keywords: Cytomegalovirus
CMV
pregnancy
transmission
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with CMV infection who are referred to the 'CMV in Pregnancy clinic' in Shaare Zedek Medical Center.

Brief summary: Analysis of several characteristics of blood from pregnant women with CMV infection according to maternal-fetal transmission. These include CMV viral load, cytokine profile in response to in-vitro stimulation with CMV peptides, meticulous analysis of anti CMV antibodies, maternal DNA polymorphism and microarray of gene expression.

Detailed description: Maternal Cytomegalovirus infection in pregnancy may cause significant morbidity in the fetus. Intrauterine CMV transmission occurs mainly during primary maternal infections, with a maternal-fetal transmission rate of about 40%. The mechanisms dictating CMV intrauterine transmission are unknown, and transmission is currently thought to be dependent on multiple factors, including the maternal and fetal immune system.

To investigate the mechanism of transmission approaching laboratory prediction of transmission, the investigators collect blood from pregnant women with primary CMV infection, and analyze several characteristics. These include CMV viral load, cytokine profile in response to in-vitro stimulation with CMV peptides, meticulous analysis of anti CMV antibodies, maternal DNA polymorphism and microarray of gene expression.

These results will be analysed according to transmission as indicated by a positive culture / Polymerase chain transcription of amniotic fluid or newborns urine / saliva.

Eligibility criteria: Inclusion Criteria:

* pregnant women
* CMV infection: primary infection: (1) CMV-specific IgG seroconversion or (2) demonstration of low avidity CMV-specific IgG antibodies, (3) the primary appearance of CMV-specific IgM with no previous IgG, and (4) CMV DNA or viral products in blood Secondary infection: appearance of CMV-specific IgM with positive IgG

Exclusion Criteria:

* CMV status unclear
* spontaneous or induced abortion
* unknown fetal outcome

Primary outcomes:
measure: Maternal-fetal transmission of CMV
timeFrame: up to 2 years
Secondary outcomes:
measure: Symptomatic congenital CMV
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Yechiel Schlesinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Yifat Eldar-Yedidia, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: