Counseling to prevent cytomegalovirus infections in pregnant women
Cytomegalovirus (CMV) Vaccines: Reinfection and Antigenic Variation
This study is testing whether counseling can help pregnant women, especially those who are already immune, avoid getting cytomegalovirus from young children to reduce the risk of passing it to their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 1 Hour to 35 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT03443791 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether a structured cognitive-behavioral counseling intervention can reduce the acquisition of human cytomegalovirus (HCMV) among pregnant women, particularly those who are already seroimmune. The intervention includes educational sessions and personalized behavioral strategies to limit exposure to HCMV, especially in households with young children. The primary goal is to achieve a 50% reduction in the incidence of congenital HCMV infections. Participants will be monitored for adherence to recommended behaviors and their understanding of HCMV transmission.
Who should consider this trial
Good fit: Ideal candidates are pregnant women in Ribeirao Preto who are receiving maternity care and are enrolled in prenatal care before 23 weeks gestation.
Not a fit: Patients who are enrolled late in their pregnancy, have major fetal anomalies, or plan to deliver at a non-study hospital may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly decrease the incidence of congenital HCMV infections, improving health outcomes for newborns.
How similar studies have performed: Previous studies have shown success in similar interventions for non-immune pregnant women, but this approach in seroimmune women is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * Women in Ribeirao Preto who receive maternity care through the Hospital Das Clinicas, University of São Paulo and the Mater Hospital * enrollment in prenatal care before 23 weeks gestation Exclusion: * late enrollment in prenatal care, after 23 weeks gestation * known major fetal anomalies or demise * planned termination of pregnancy * intention of the patient to deliver at a non-study hospital * referral for high risk prenatal care
Where this trial is running
São Paulo
- University of Sao Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: William J. Britt, MD — The University of Alabama at Birmingham
- Study coordinator: Marisa Mussi-Pinhata, MD
- Email: mussi.pinhata@pq.cnpq.br
- Phone: 551636022479
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.