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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Cytomegalovirus; Cytomegalovirus Infections

Treatments: Procedure: Saliva swab; Procedure: Urine sampling; Procedure: Vaginal swab; Procedure: Blood sample; Procedure: Cord blood sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT01251744

113134

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol .
• A pregnant female, 18 years of age or older at the time of study enrolment.
• Women with confirmed primary CMV infection.
• Written informed consent obtained from the subject.

Exclusion criteria

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product.
• Previous vaccination against CMV infection.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination
• Major congenital defects, serious chronic illness or organ transplantation.
• Administration of immunoglobulins and/or any blood products within the three months preceding study enrolment or during the pregnancy.
• Documented Human immunodeficiency virus (HIV)-positive subject.
• Gestational age of more than 34 weeks, as determined by foetal ultrasound.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

CMV Mothers' Group

Experimental group

Description:

Pregnant subjects with confirmed primary CMV infection.

Treatment:

Procedure: Urine sampling

Procedure: Vaginal swab

Procedure: Cord blood sample

Procedure: Saliva swab

Procedure: Blood sample

CMV Newborns' Group

Experimental group

Description:

Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.

Treatment:

Procedure: Urine sampling

Procedure: Vaginal swab

Procedure: Cord blood sample

Procedure: Saliva swab

Procedure: Blood sample