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

NCT04615715 | Active Not Recruiting

• 2 other identifiers: IRB-300004979R01HD098352
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maternal Cytomegalovirus Infections; Cytomegalovirus Congenital

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Enrollment(baseline) until delivery, up to 32 weeks

Secondary Outcomes (4)

• Change in self-reported CMV risk behaviors and protective behaviors

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

• Frequency of CMV shedding

  Enrollment(baseline) until delivery, up to 32 weeks

• Proportion of infants with congenital CMV

  Delivery

• Frequency of new CMV variants

  Enrollment(baseline) until delivery up to 32 weeks

Other Outcomes (5)

• CMV viral loads

  Enrollment(baseline) until delivery, up to 32 weeks

• Risk factors for CMV infections

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

• Change in anxiety after intervention

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

Study Arms (2)

CMV Risk-Reduction Intervention

EXPERIMENTAL

One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages

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

Behavioral: Stress Reduction Messaging

Interventions

Stress Reduction Messaging BEHAVIORAL

Stress Reduction Messaging

Stress Reduction Messaging

CMV Risk-Reduction Intervention BEHAVIORAL

CMV Risk-Reduction Intervention

CMV Risk-Reduction Intervention

Eligibility Criteria

• Age: 14 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Karen B Fowler

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory personnel will not know the participant's intervention status.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 4, 2020
• Study Start: January 11, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)