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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CMV reinfections in women with non-primary infections
CMV seroconversion rate in CMV seronegative women
Secondary outcome measures
Change in self-reported CMV risk behaviors and protective behaviors
Frequency of CMV shedding
Frequency of new CMV variants
+1 more
Other outcome measures
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
1,586 Previous Clinical Trials
2,279,392 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,673,890 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
Cytomegalovirus Infection Research Study Groups: CMV Risk-Reduction Intervention, Stress Reduction Messaging
Cytomegalovirus Infection 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this investigation?

"Affirmative, according to the information hosted on clinicaltrials.gov this research study is actively searching for participants. This trial was initially posted on November 1st 2021 and last modified on December 6th 2021; as of now there remains a need for 840 individuals at one medical facility."

Answered by AI

Does this experiment include elderly individuals in its participant demographics?

"This trial requires that applicants are between the ages of 14 and 39. There are 26 studies targeting those under the age of majority, while 37 trials cater to individuals over 65 years old."

Answered by AI

What is the anticipated outcome of this experiment?

"This clinical trial, monitored from the beginning of enrolment until delivery (32 weeks), is designed to evaluate CMV reinfection rates in non-primary infection women. Its secondary goals are to assess the frequency of CMV shedding through PCR analysis on saliva, urine, and blood specimens; measure any changes in self-reported risk behaviours and protective measures with a questionnaire at 12 week post intervention; as well as determine how often new variants of CMV appear via serological screening assays combined with advanced sequencing methods."

Answered by AI

Is this trial of medical treatment still recruiting participants?

"As found on the clinicaltrials.gov website, this medical trial is actively recruiting participants and has been since it was initially published in November 2021; the listing was recently updated in December of that same year."

Answered by AI

Is it possible for me to be a participant in this scientific endeavor?

"This research project is seeking 840 individuals aged between 14 and 39 that have contracted cytomegalovirus. To qualify, applicants must be enrolled in prenatal care before the 20th week of gestation and display CMV seronegative status or a pre-existing maternal infection through high IgG avidity index or a positive CMV IgG with negative immunoglobulin M (IgM)."

Answered by AI
~143 spots leftby Dec 2024