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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 : Unknown
Verified December 2017 by Yechiel Schlesinger, Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : May 2, 2014
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Yechiel Schlesinger, Shaare Zedek Medical Center

Tracking Information
First Submitted Date April 27, 2014
First Posted Date May 2, 2014
Last Update Posted Date January 3, 2018
Study Start Date June 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2014)
Maternal-fetal transmission of CMV [ Time Frame: up to 2 years ]
Positive CMV culture and / or PCR in amniotic fluid or newborns urine.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 1, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, serum, plasma, peripheral blood mono-nuclear cells , DNA, RNA
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.
Condition
  • Pregnancy
  • Cytomegalovirus Infections
  • Congenital Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 1, 2014)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02129465
Other Study ID Numbers CMV_transmission.CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yechiel Schlesinger, Shaare Zedek Medical Center
Study Sponsor Shaare Zedek Medical Center
Collaborators Not Provided
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
PRS Account Shaare Zedek Medical Center
Verification Date December 2017