A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
Status:
Completed
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects.
When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue,
weakness, fever, swollen glands). Most people in the United States are infected during
childhood or as adults if they work around children. Pregnant women, who have not been
infected with CMV in the past and become infected during pregnancy (i.e. a primary
infection), may cause their babies to get infected with CMV. Babies that are infected may
develop permanent disabilities including hearing loss and a small portion will die from the
infection.
Currently it is not routine practice to screen pregnant women for CMV infection.
Additionally, there is no agreement about how to evaluate and manage pregnant women infected
with CMV for the first time. There is also no evidence that treatment is beneficial for the
baby.
The purpose of this research study is to determine whether treating pregnant women who have a
primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.
Phase:
Phase 3
Details
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)