NCT04615715

Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 582 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 14 Years – 39 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.

Detailed description

Pregnant women will be recruited into the study following their first prenatal visit. After enrollment, they will be randomized to either the CMV risk-reduction intervention or an attention-matched control stress-reduction group stratified by their CMV serostatus. 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

• Maternal Cytomegalovirus Infections
• Cytomegalovirus Congenital

Interventions

Type	Name	Description
BEHAVIORAL	CMV Risk-Reduction Intervention	CMV Risk-Reduction Intervention
BEHAVIORAL	Stress Reduction Messaging	Stress Reduction Messaging

Timeline

• Start date: 2021-01-11
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2020-11-04
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States