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.
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Number of Participants With the Composite Primary Outcome
Timeframe: From randomization through 3 weeks of life
Number of Participants Who Had a Fetus or Neonate With CMV Infection
Timeframe: From randomization through 3 weeks of life
Number of Participants Who Had a Neonatal Death Without CMV Infection
Timeframe: From randomization through 3 weeks of life
Number of Participants With a Fetal or Neonatal Death With Proven CMV Infection
Timeframe: From randomization through 3 weeks of life
Number of Participants With Fetal Death Without Proven CMV Infection
Timeframe: From randomization through delivery