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

Cytomegalovirus Congenital Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cytomegalovirus Congenital
• Cytomegalovirus Infections
• Maternal Cytomegalovirus Infections

• NCT number: NCT04615715
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Contact: Karen B Fowler, DrPH
• Phone: 205 638 2549
• Email: kfowler@uab.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2021
• Completion date: March 31, 2025