November 9, 2020

A randomized trial to screen for cytomegalovirus during pregnancy



Cytomegalovirus (CMV) is the most common congenital infection and the most common cause of non-genetic hearing loss in children. Unless it is highly suspected, congenital CMV often goes undetected at birth since most infected newborns are asymptomatic.  Approximately 1% or 44,000 infants are diagnosed per year with a 7-12% rate of mortality from the infection. Up to 8,000 of infants infected develop permanent disabilities such as hearing loss, developmental and motor delay, vision loss, microcephaly, and seizures. The severity of congenital infection is greatest with a maternal CMV infection, with 40% acquiring CMV infection in utero when mothers are infected. Currently, there is no proven method to prevent congenital CMV infection and no cure.

Researchers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units Network (MFMU Network) conducted a randomized trial to prevent congenital CMV. The objective of the study was to determine whether maternal administration of CMV hyperimmune globulin prior to 24 weeks gestation in women diagnosed with primary CMV infection reduces the rate of CMV infection. Universal screening for CMV in pregnancy is not currently supported due to a lack of accuracy in testing, as well as limited options for treatment. For the trial the Network screened over 200,000 pregnant women.  Publication of the results is expected soon.  Follow-up of the children to age two is continuing.

The Geneva Foundation served as a coordination site for the Data Coordinating Center of the MFMU Network (the George Washington University Biostatistics Center) for this CMV trial. Geneva enabled screening and enrollment of program participants at a military center according to the MFMU-approved protocol.

To respond to the need for well-designed clinical trials in maternal-fetal medicine, the MFMU Network was created in 1986 and conducts clinical research studies in obstetrics and perinatal medicine. The MFMU Network consists of several major academic clinical centers, a data coordinating center, and the Institute itself. Studies are aimed at reducing maternal, fetal and infant morbidity related to preterm birth, fetal growth abnormalities, and maternal complications and to provide the rationale for evidence-based, cost-effective, obstetric practice. Currently, 12 medical centers across the U.S. are participating in this program.

Geneva is proud to support this trial and further advance women’s health in the military and global community.