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Completed

NCT Number: NCT04615715

Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

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.

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Key information

Conditions

Maternal Cytomegalovirus Infections Cytomegalovirus Congenital Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

14 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMV Risk-Reduction Intervention

Behavioral

CMV Risk-Reduction Intervention

Stress Reduction Messaging

Behavioral

Stress Reduction Messaging

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in self-reported CMV risk behaviors and protective behaviors

    Time frame: Enrollment (baseline) to 12 weeks after enrollment (follow-up)

    Change in the CMV risk behaviors and protective behaviors self-reported on the CMV risk behaviors questionnaire at 12 weeks post intervention.

  2. Frequency of CMV shedding

    Time frame: Enrollment(baseline) until delivery, up to 32 weeks

    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.

  3. Proportion of infants with congenital CMV

    Time frame: Delivery

    The proportion of infants with a positive saliva PCR test for CMV in the first 21 days of life.

  4. Frequency of new CMV variants

    Time frame: Enrollment(baseline) until delivery up to 32 weeks

    Number of participants with new CMV variants identified by a combination of serological screening assays and next generation sequencing of viral DNA.

Other outcomes

  1. CMV viral loads

    Time frame: Enrollment(baseline) until delivery, up to 32 weeks

    CMV viral loads indicated by the quantity of CMV DNA by PCR in saliva, urine, vaginal, or blood specimens.

  2. Risk factors for CMV infections

    Time frame: Enrollment(baseline) to 12 weeks after enrollment (follow-up)

    Identification of possible CMV exposures during pregnancy through self-reported exposure questionnaires given at baseline, 6 weeks, and 12 weeks.

  3. Change in anxiety after intervention

    Time frame: Enrollment(baseline) to 12 weeks after enrollment (follow-up)

    Changes in anxiety measured by the Kessler-10 Psychological Distress Scale (K10) administered pre- and post-intervention. K10 scores range from 10 to 50, with 50 indicating highest risk of anxiety.

  4. Change in CMV knowledge

    Time frame: Enrollment(baseline) to 12 weeks after enrollment (follow-up)

    Change in CMV knowledge indicated by self-report on CMV knowledge questionnaire administered pre- and post-intervention to all participants. The questionnaire will be assigned a score of 0 -18 based on the participants' answers, with a higher score indicating desired CMV knowledge.

  5. Acceptability of the educational intervention

    Time frame: Enrollment(baseline) to 12 weeks after enrollment (follow-up)

    Acceptability of prevention messages measured post-intervention by a study assessment questionnaire that provides participant feedback and rating of the intervention at 12 weeks.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2020
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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