Immunological Characteristics of Maternal-fetal Transmission of Cytomegalovirus in Pregnancy

Pregnancy Clinical Trial

— CMV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02129465
• Other study ID #: CMV_transmission.CTIL
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2014
• Last updated: December 31, 2017
• Start date: June 2014
• Est. completion date: May 2019

Study information

• Verified date: December 2017
• Source: Shaare Zedek Medical Center
• Contact: Yechiel Schlesinger, MD
• Phone: 972-2-6555-197
• Email: s.yechiel[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Congenital Infection
• Cytomegalovirus Infections
• Infection
• Pregnancy

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal-fetal transmission of CMV	Positive CMV culture and / or PCR in amniotic fluid or newborns urine.	up to 2 years
Secondary	Symptomatic congenital CMV	Any clinical findings defining the patient as having symptomatic infection such as microcephaly, intra-cranial calcifications, sensory-neuronal hearing loss, etc.	up to 2 years