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

Not Applicable

Recruiting

• Conditions: Maternal Cytomegalovirus Infections; Cytomegalovirus Congenital
• Interventions: Behavioral: Stress Reduction Messaging; Behavioral: CMV Risk-Reduction Intervention

• Registration Number: NCT04615715
• Lead Sponsor: University of Alabama at Birmingham

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-04
• Study Start: 2021-01-11
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 840

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)

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress Reduction Messaging	Stress Reduction Messaging	One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages
CMV Risk-Reduction Intervention	CMV Risk-Reduction Intervention	One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages

Primary Outcome Measures

Name	Time	Method
CMV reinfections in women with non-primary infections	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.
CMV seroconversion rate in CMV seronegative women	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.

Secondary Outcome Measures

Name	Time	Method
Change in self-reported CMV risk behaviors and protective behaviors	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.
Frequency of CMV shedding	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.
Proportion of infants with congenital CMV	Delivery	The proportion of infants with a positive saliva PCR test for CMV in the first 21 days of life.
Frequency of new CMV variants	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States