Maternal Cytomegalovirus InfectionsNCT04615715
Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
A study testing CMV Risk-Reduction Intervention and Stress Reduction Messaging in people with Maternal Cytomegalovirus Infections and Cytomegalovirus Congenital, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women. Read more about this study
- Who is it for?
- Ages 14 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Cytomegalovirus Infections, Cytomegalovirus Congenital
- What is being tested?
- CMV Risk-Reduction Intervention and Stress Reduction Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 582 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 39 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.
Read the detailed description
Pregnant women will be recruited into the study following their first prenatal visit. After enrollment, they will be randomized to either the CMV risk-reduction intervention or an attention-matched control stress-reduction group stratified by their CMV serostatus.
Women in both groups will attend an individualized behavioral skills session, watch a short video, receive a take-home packet, receive weekly text messages for 12 weeks that reinforce the experimental and control health messages, and attend follow-up visits at 6 and 12 weeks. Saliva, urine, vaginal, and blood specimens will be collected at enrollment and 6 and 12 weeks follow-up visits. Additionally, at-home saliva and vaginal specimen collection will occur at 3 and 9 weeks and once during the third trimester of pregnancy. At delivery, a saliva specimen will be collected from both the mother and infant, along with a remnant cord blood specimen.
- Being tested
- CMV Risk-Reduction Intervention, Stress Reduction Messaging
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV Risk-Reduction InterventionBehavioural
CMV Risk-Reduction Intervention
Stress Reduction MessagingBehavioural
Stress Reduction Messaging
| Study group | Role | What they receive |
|---|---|---|
| CMV Risk-Reduction Intervention | Experimental | One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages Receives: Behavioral: CMV Risk-Reduction Intervention |
| Stress Reduction Messaging | Placebo comparator | One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages Receives: Behavioral: Stress Reduction Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV seroconversion rate in CMV seronegative women
CMV seroconversion is defined as the development of CMV immunoglobulin G (IgG) antibody in the serum of women who did not have antibodies previously. The CMV seroconversion rate will be assessed in participants.
Measured: Enrollment (baseline) until delivery, up to 32 weeks
CMV reinfections in women with non-primary infections
Reinfection will be defined by a combination of strain-specific serologic assays, next-generation sequencing, and virus shedding. The number of CMV reinfections will be assessed in participants.
Measured: Enrollment(baseline) until delivery, up to 32 weeks
Secondary outcomes (4)
Change in self-reported CMV risk behaviors and protective behaviors
Change in the CMV risk behaviors and protective behaviors self-reported on the CMV risk behaviors questionnaire at 12 weeks post intervention.
Measured: Enrollment (baseline) to 12 weeks after enrollment (follow-up)
Frequency of CMV shedding
Number of participants shedding CMV in their specimens collected during pregnancy. CMV shedding is indicated by the presence of CMV DNA by polymerase chain reaction assay (PCR) in saliva, urine, vaginal, or blood specimens.
Measured: Enrollment(baseline) until delivery, up to 32 weeks
Proportion of infants with congenital CMV
The proportion of infants with a positive saliva PCR test for CMV in the first 21 days of life.
Measured: Delivery
Frequency of new CMV variants
Number of participants with new CMV variants identified by a combination of serological screening assays and next generation sequencing of viral DNA.
Measured: Enrollment(baseline) until delivery up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start11 Jan 2021
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Karen Fowler, University of Alabama at Birmingham
- Investigators
- Karen B Fowler, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615715
- Sponsor's protocol ID
- IRB-300004979
- Other IDs
- R01HD098352
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2020
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests for data sharing may be considered on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
- ClinicalTrials.gov ID
- NCT04615715
- Acronym / sponsor ID
- IRB-300004979
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.
Detailed description
Pregnant women will be recruited into the study following their first prenatal visit. After enrollment, they will be randomized to either the CMV risk-reduction intervention or an attention-matched control stress-reduction group stratified by their CMV serostatus.
Women in both groups will attend an individualized behavioral skills session, watch a short video, receive a take-home packet, receive weekly text messages for 12 weeks that reinforce the experimental and control health messages, and attend follow-up visits at 6 and 12 weeks. Saliva, urine, vaginal, and blood specimens will be collected at enrollment and 6 and 12 weeks follow-up visits. Additionally, at-home saliva and vaginal specimen collection will occur at 3 and 9 weeks and once during the third trimester of pregnancy. At delivery, a saliva specimen will be collected from both the mother and infant, along with a remnant cord blood specimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMV Risk-Reduction Intervention | Experimental | Behavioral: CMV Risk-Reduction InterventionOne-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages |
| Stress Reduction Messaging | Placebo comparator | Behavioral: Stress Reduction MessagingOne-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages |
Who may qualify
- Ages
- 14 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMV Risk-Reduction InterventionCMV Risk-Reduction Intervention | Behavioural | CMV Risk-Reduction Intervention |
| Stress Reduction MessagingStress Reduction Messaging | Behavioural | Stress Reduction Messaging |
Primary outcome
CMV seroconversion rate in CMV seronegative women
Time frame: Enrollment (baseline) until delivery, up to 32 weeks
CMV seroconversion is defined as the development of CMV immunoglobulin G (IgG) antibody in the serum of women who did not have antibodies previously. The CMV seroconversion rate will be assessed in participants.
CMV reinfections in women with non-primary infections
Time frame: Enrollment(baseline) until delivery, up to 32 weeks
Reinfection will be defined by a combination of strain-specific serologic assays, next-generation sequencing, and virus shedding. The number of CMV reinfections will be assessed in participants.
4 secondary outcomes
Change in self-reported CMV risk behaviors and protective behaviors
Time frame: Enrollment (baseline) to 12 weeks after enrollment (follow-up)
Frequency of CMV shedding
Time frame: Enrollment(baseline) until delivery, up to 32 weeks
Proportion of infants with congenital CMV
Time frame: Delivery
Frequency of new CMV variants
Time frame: Enrollment(baseline) until delivery up to 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. Requests for data sharing may be considered on a case-by-case basis.
Related trials for Maternal Cytomegalovirus Infections
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Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
Cytomegalovirus Infections, Maternal Primary Cytomegalovirus Infection
Active, not recruitingObservational study
Non Primary HCMV Infection: Natural History and Immune Response
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen B Fowler principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMV Risk-Reduction Intervention and Stress Reduction Messaging in people with Maternal Cytomegalovirus Infections and Cytomegalovirus Congenital, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV seroconversion rate in CMV seronegative women (time frame: Enrollment (baseline) until delivery, up to 32 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.