NCT02129465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

4.5 years

First QC Date

April 27, 2014

Last Update Submit

December 31, 2017

Conditions

PregnancyCytomegalovirus InfectionsCongenital Infection

Keywords

CytomegalovirusCMVpregnancytransmission

Outcome Measures

Primary Outcomes (1)

  • Maternal-fetal transmission of CMV

    Positive CMV culture and / or PCR in amniotic fluid or newborns urine.

    up to 2 years

Secondary Outcomes (1)

  • Symptomatic congenital CMV

    up to 2 years

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women with CMV infection who are referred to the 'CMV in Pregnancy clinic' in Shaare Zedek Medical Center.

You may qualify if:

  • 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

You may not qualify if:

  • CMV status unclear
  • spontaneous or induced abortion
  • unknown fetal outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, peripheral blood mono-nuclear cells , DNA, RNA

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Yechiel Schlesinger, MD

    Shaare Zedek Medical Center, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

  • Yifat Eldar-Yedidia, Ph.D.

    Shaare Zedek Medical Center, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yechiel Schlesinger, MD

CONTACT

972-2-6555-197s.yechiel@gmail.com

Yifat Eldar-Yedidia, Ph.D.

CONTACT

972-54-6878-093yifat4@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, division of pediatrics

Study Record Dates

First Submitted

April 27, 2014

First Posted

May 2, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2018

Study Completion

May 1, 2019

Last Updated

January 3, 2018

Record last verified: 2017-12

Locations

IL(1)