Immunological Characteristics of Maternal-fetal Transmission of Cytomegalovirus in Pregnancy

• Conditions: Cytomegalovirus Infections; Pregnancy; Congenital Infection

• Registration Number: NCT02129465
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2014-04-27
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-02
• Study Start: 2014-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-31
• Last Update Posted: 2018-01-03
• Primary Completion: 2018-12
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal-fetal transmission of CMV	up to 2 years	Positive CMV culture and / or PCR in amniotic fluid or newborns urine.

Secondary Outcome Measures

Name	Time	Method
Symptomatic congenital CMV	up to 2 years	Any clinical findings defining the patient as having symptomatic infection such as microcephaly, intra-cranial calcifications, sensory-neuronal hearing loss, etc.

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel