Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
NCT ID: NCT04615715
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
840 participants
INTERVENTIONAL
2021-01-11
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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CMV Risk-Reduction Intervention
One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages
CMV Risk-Reduction Intervention
CMV Risk-Reduction Intervention
Stress Reduction Messaging
One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages
Stress Reduction Messaging
Stress Reduction Messaging
Interventions
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CMV Risk-Reduction Intervention
CMV Risk-Reduction Intervention
Stress Reduction Messaging
Stress Reduction Messaging
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
39 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Karen Fowler
Primary Investigator
Principal Investigators
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Karen B Fowler
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Other Identifiers
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IRB-300004979
Identifier Type: -
Identifier Source: org_study_id