CompletedNot Applicable

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

Belgium160 participantsStarted 2010-12-09

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection

Timeframe: At Month 0

Number of Subjects With CMV Presence in the Urine

Timeframe: Within 10 days post-delivery (Days 0-9)

Number of Subjects With CMV Presence in the Amniotic Fluid

Timeframe: Within 10 days post-delivery (Days 0-9)

Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus

Timeframe: Within 10 days post-delivery (Days 0-9)

Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions

Timeframe: At Month 0

Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions

Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)

Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status

Timeframe: At Month 0

Trial details

NCT IDNCT01251744

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11-06

Results submitted2017-06-09

View on ClinicalTrials.gov More Infections, Cytomegalovirus trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection

Timeframe: At Month 0

Number of Subjects With CMV Presence in the Urine

Timeframe: Within 10 days post-delivery (Days 0-9)

Number of Subjects With CMV Presence in the Amniotic Fluid

Timeframe: Within 10 days post-delivery (Days 0-9)

Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus

Timeframe: Within 10 days post-delivery (Days 0-9)

Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions

Timeframe: At Month 0

Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions

Timeframe: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)

Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status

Timeframe: At Month 0