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Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

NCT01251744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-06-29

Study results available
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Summary

This study is designed to evaluate maternal virological and immunological parameters to determine their ability to predict congenital cytomegalovirus (CMV) infection. When a pregnant woman is infected with CMV, her immune system (which protects her from infection) is activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine, vaginal secretions). The aim of this study is to find out if there is a link between either the pregnant woman's immune response or the presence of the virus in these bodily fluids and the child/foetus being infected with the virus.

Conditions

  • Infections, Cytomegalovirus
  • Cytomegalovirus Infections

Interventions

PROCEDURE

Blood sample

Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.

PROCEDURE

Cord blood sample

Cord blood sample taken at the time of delivery.

PROCEDURE

Saliva swab

Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.

PROCEDURE

Urine sampling

Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.

PROCEDURE

Vaginal swab

Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-09
Primary Completion
2013-11-06
Completion
2015-06-17

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01251744 on ClinicalTrials.gov