Immunological Characteristics of Maternal-fetal Transmission of Cytomegalovirus in Pregnancy

Correlates of Maternal Characteristics in CMV Infection in Pregnancy With Maternal-fetal Transmission.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02129465

Acronym

CMV

Enrollment

100

Registered

2014-05-02

Start date

2014-06-30

Completion date

2019-05-31

Last updated

2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Infection, Cytomegalovirus Infections, Pregnancy

Keywords

Cytomegalovirus, CMV, pregnancy, transmission

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 42 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Israel

Contacts

Primary ContactYechiel Schlesinger, MD

s.yechiel@gmail.com972-2-6555-197

Backup ContactYifat Eldar-Yedidia, Ph.D.

yifat4@gmail.com972-54-6878-093

Outcome results