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Immunological Characteristics of Maternal-fetal Transmission of Cytomegalovirus in Pregnancy (CMV)

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ClinicalTrials.gov Identifier: NCT02129465
Recruitment Status : Recruiting
First Posted : May 2, 2014
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Yechiel Schlesinger, 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.

Condition or disease
Pregnancy Cytomegalovirus Infections Congenital Infection

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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlates of Maternal Characteristics in CMV Infection in Pregnancy With Maternal-fetal Transmission.
Study Start Date : June 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Maternal-fetal transmission of CMV [ Time Frame: up to 2 years ]
    Positive CMV culture and / or PCR in amniotic fluid or newborns urine.


Secondary Outcome Measures :
  1. Symptomatic congenital CMV [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
whole blood, serum, plasma, peripheral blood mono-nuclear cells , DNA, RNA


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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129465


Contacts
Contact: Yechiel Schlesinger, MD 972-2-6555-197 s.yechiel@gmail.com
Contact: Yifat Eldar-Yedidia, Ph.D. 972-54-6878-093 yifat4@gmail.com

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Yifat Eldar-Yedidia, Ph.D.    972-54-6878093    yifat4@gmail.com   
Contact: Yechiel Schlesinger    972-2-6555197    s.yechiel@gmail.com   
Principal Investigator: Yechiel Schlesinger, M.D.         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Yechiel Schlesinger, MD Shaare Zedek Medical Center, Jerusalem, Israel
Principal Investigator: Yifat Eldar-Yedidia, Ph.D. Shaare Zedek Medical Center, Jerusalem, Israel

Responsible Party: Yechiel Schlesinger, Head, division of pediatrics, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02129465     History of Changes
Other Study ID Numbers: CMV_transmission.CTIL
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Keywords provided by Yechiel Schlesinger, Shaare Zedek Medical Center:
Cytomegalovirus
CMV
pregnancy
transmission

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases