NCT01081379

Brief Summary

The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission.

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 Feb 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

March 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
3.9 years until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

7.5 years

First QC Date

March 4, 2010

Last Update Submit

November 10, 2019

Conditions

Pregnant WomenCytomegalovirus Infections

Keywords

Cytomegalovirus InfectionsPregnancyT-LymphocytesTransmission

Outcome Measures

Primary Outcomes (1)

  • Maternal-Fetal transmission of CMV

    1 year

Study Arms (2)

pre-conception immunity

pre-conception immunity- pregnant women with CMV seropositive

primary CMV infection

primary CMV infection- pregnant women with primary CMV infection (defined as CMV IgG sero-conversion, the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies).

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with primary CMV

You may qualify if:

  • Pregnant women
  • CMV IgG sero-conversion or the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies.

You may not qualify if:

  • Underlying immune deficiencies
  • Other pregnancy complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Yechiel Schlesinger, M.D.

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yechiel Schlesinger, M.D.

CONTACT

972-2-6555-147s.yechiel@gmail.com

Yifat Yedidia-Eldar, Ph. D.

CONTACT

972-26666-775yifat4@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yechiel Schlesinger, MD, Shaare Zedek Medical Center.

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

February 1, 2014

Primary Completion

August 1, 2021

Study Completion

August 1, 2022

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

IL(1)