Prenatal education may stop common virus that harms babies
NCT ID NCT04615715
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether teaching pregnant women about CMV risks and protective behaviors could prevent them from catching the virus. 582 women were enrolled early in pregnancy. The intervention involved brief counseling sessions. The goal was to reduce CMV infections that can cause birth defects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- behavioral intervention (CMV risk-reduction education)
- What this could lead to
- If successful, this approach could offer a simple, drug-free way to prevent CMV infection during pregnancy, reducing the risk of birth defects.
- What could go wrong
- This is a completed behavioral study, not a drug trial. The intervention may not change behavior enough to lower infection rates, and results may not apply to all populations.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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582 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 39 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * enrollment in prenatal care before 20 weeks gestation * absence of CMV IgG on serological testing indicating CMV seronegative status or CMV positive (nonprimary) defined as maternal CMV infection pre-dating pregnancy defined by a high IgG avidity index or a positive CMV IgG in the presence of a negative CMV immunoglobulin M (IgM) Exclusion Criteria: * known major fetal anomalies or demise * planned termination of pregnancy * planned use of immune globulin, ganciclovir, or valganciclovir * maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection medications) * pre-enrollment ultrasound suggestive of established fetal CMV infection or positive fetal CMV results from culture or PCR * pre-enrollment CMV seroconversion or primary CMV infection in pregnancy * unable to determine if CMV infection is a nonprimary infection due to intermediate or undefined CMV serological test results * pre-enrollment blood, ultrasound, or amniotic fluid testing indicating congenital infection with rubella, syphilis, varicella, parvovirus, toxoplasmosis or other congenital infection * intention of the patient or of the managing obstetricians for the delivery to be outside of the University of Alabama at Birmingham hospital
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States