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Behavioral Intervention for CMV in Pregnancy

N/A
Recruiting
Led By Karen B Fowler
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
planned use of immune globulin, ganciclovir, or valganciclovir
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery

Summary

This trial will test if a short intervention at a prenatal clinic can help stop CMV infections in pregnant women.

Who is the study for?
This trial is for pregnant women who are early in their prenatal care (before 20 weeks gestation) and have tested negative or nonprimary positive for CMV. It's not suitable for those planning to deliver outside of the University of Alabama at Birmingham hospital, with known major fetal anomalies, planned pregnancy termination, or use of certain antiviral drugs.
What is being tested?
The study tests a brief behavioral intervention aimed at reducing the risk of catching CMV during pregnancy. Participants will receive information on how to lower their chances of infection as well as stress reduction messaging.
What are the potential side effects?
Since this trial involves educational interventions rather than medications, there are no direct side effects from treatments like you would expect with drug trials.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled to use immune globulin or antiviral medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment(baseline) until delivery up to 32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment(baseline) until delivery up to 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CMV reinfections in women with non-primary infections
CMV seroconversion rate in CMV seronegative women
Secondary study objectives
Change in self-reported CMV risk behaviors and protective behaviors
Frequency of CMV shedding
Frequency of new CMV variants
+1 more
Other study objectives
Acceptability of the educational intervention
CMV viral loads
Change in CMV knowledge
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CMV Risk-Reduction InterventionExperimental Treatment1 Intervention
One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages
Group II: Stress Reduction MessagingPlacebo Group1 Intervention
One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,645 Previous Clinical Trials
2,342,012 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,053 Previous Clinical Trials
2,730,828 Total Patients Enrolled
Karen B FowlerPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

CMV Risk-Reduction Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04615715 — N/A
Congenital CMV Research Study Groups: CMV Risk-Reduction Intervention, Stress Reduction Messaging
Congenital CMV Clinical Trial 2023: CMV Risk-Reduction Intervention Highlights & Side Effects. Trial Name: NCT04615715 — N/A
CMV Risk-Reduction Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04615715 — N/A
~185 spots leftby Dec 2025
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