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 range

18 Years

Sex

FEMALE

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years

Sex

FEMALE

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