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
|Condition or disease|
|Pregnancy Cytomegalovirus Infections Congenital Infection|
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|
|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|
- Maternal-fetal transmission of CMV [ Time Frame: up to 2 years ]Positive CMV culture and / or PCR in amniotic fluid or newborns urine.
- 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
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
|Contact: Yechiel Schlesinger, MDfirstname.lastname@example.org|
|Contact: Yifat Eldar-Yedidia, Ph.D.||email@example.com|
|Shaare Zedek Medical Center||Recruiting|
|Jerusalem, Israel, 91031|
|Contact: Yifat Eldar-Yedidia, Ph.D. 972-54-6878093 firstname.lastname@example.org|
|Contact: Yechiel Schlesinger 972-2-6555197 email@example.com|
|Principal Investigator: Yechiel Schlesinger, M.D.|
|Principal Investigator:||Yechiel Schlesinger, MD||Shaare Zedek Medical Center, Jerusalem, Israel|
|Principal Investigator:||Yifat Eldar-Yedidia, Ph.D.||Shaare Zedek Medical Center, Jerusalem, Israel|