Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 14
Maximum Age: 39
Healthy Volunteers: t
View:
• 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)
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Karen B Fowler, DrPH
kfowler@uab.edu
205 638 2549
Time Frame
Start Date: 2021-01-11
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 840
Treatments
Experimental: CMV Risk-Reduction Intervention
One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages
Placebo_comparator: Stress Reduction Messaging
One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)