Behavioral intervention to reduce maternal CMV infections during pregnancy
Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
This study is testing a new program to help pregnant women reduce their risk of getting cytomegalovirus (CMV) infections by providing them with support and education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 14 Years to 39 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04615715 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a brief prenatal clinic-based behavioral intervention aimed at reducing the risk of maternal cytomegalovirus (CMV) infections during pregnancy. Pregnant women will be randomized into either a CMV risk-reduction intervention group or a control group focused on stress reduction. Participants will engage in individualized behavioral skills sessions, watch educational videos, and receive ongoing support through text messages over 12 weeks. Specimens will be collected at various points to monitor CMV infection status and outcomes for both mothers and infants.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who are enrolled in prenatal care before 20 weeks gestation and are either CMV seronegative or have a nonprimary CMV infection.
Not a fit: Patients with known major fetal anomalies, planned pregnancy termination, or those with maternal immune impairment will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of maternal CMV infections, leading to better health outcomes for both mothers and their infants.
How similar studies have performed: While there is limited data on similar behavioral interventions specifically targeting CMV, other studies have shown success in using behavioral approaches to reduce infection risks in pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
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) 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Karen B Fowler — University of Alabama at Birmingham
- Study coordinator: Karen B Fowler, DrPH
- Email: kfowler@uab.edu
- Phone: 205 638 2549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.