CompletedPhase 2/3

Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection

Italy124 participantsStarted 2009-06

Plain-language summary

The aim of this trial is to verify, under controlled conditions, the reported efficacy of human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women suffering from primary HCMV infection for the prevention of intrauterine HCMV transmission.

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: * pregnant women (in vitro fertilization permitted) * \>= 18 years of age * primary HCMV infection at 5-26 weeks' gestation * \<= 6 weeks from presumed onset of infection * gestational age between 5-32 weeks' gestation * written informed consent Exclusion Criteria: * multiple pregnancy * history of HIV or HBV or HCV infection * known immunodeficiency or immunosuppression * congenital or acquired autoimmune disease * known intolerance to protein of human origin * known intolerance to immune globulin * history of adverse effects to vaccination * hypersensitivity to human immune globulin (pathological IgG or IgA deficiences) * renal failure * serious organic or psychiatric disease * lack of motivation to participate in the study * women unable to satisfy study requirements * women not willing or unable to provide written informed consent * women not willing to give consent to transmission of anonymised data

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

Evidence of congenital HCMV infection in the fetus/newborn

Timeframe: At amniocentesis and/or within one week after birth

Trial details

NCT IDNCT00881517

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-10

View on ClinicalTrials.gov More Cytomegalovirus Infection trials