Amniocentesis to diagnose congenital cytomegalovirus infection following maternal primary infection

Congenital cytomegalovirus infection following maternal primary cytomegalovirus infection affects approximately 0.4% of newborns in the United States but may be hard to diagnose prenatally. To evaluate the current sensitivity and specificity of amniocentesis in detecting congenital cytomegalovirus infection. Secondary analysis of a multicenter randomized placebo-controlled trial designed to evaluate whether cytomegalovirus hyperimmune globulin reduces congenital cytomegalovirus infection in neonates of individuals diagnosed with primary cytomegalovirus infection before 24 weeks of gestation. At randomization, subjects had no clinical evidence of fetal infection. Eligible subjects were randomized to monthly infusions of cytomegalovirus hyperimmune globulin or placebo until delivery. Although not required by the trial protocol, amniocentesis following randomization was permitted. The fetuses and neonates were tested for the presence of cytomegalovirus at delivery. Comparisons were made between those with and without amniocentesis and between those with cytomegalovirus-positive and negative results, using chi-square or Fisher exact test for categorical variables and the Wilcoxon rank sum test or t test for continuous variables. A P value of <.05 was="" considered="" significant.="" from="" to="" subjects="" were="" included="" of="" whom="" underwent="" amniocentesis.="" cytomegalovirus="" results="" available="" for="" fetuses="" and="" neonates.="" fourteen="" amniocenteses="" positive="" gestational="" age="" at="" amniocentesis="" similar="" between="" those="" with="" without="" present="" as="" the="" interval="" maternal="" diagnosis="" prevalence="" fetal="" or="" neonatal="" infection="" neonates="" all="" a="" had="" confirmed="" delivery="" did="" group="" negative="" sensitivity="" confidence="" specificity="" predictive="" value="" amniocentesis-positive="" pregnancies="" delivered="" an="" earlier="" vs="" weeks="" p="" lower="" birthweights="" g="" than="" amniocentesis-negative="" pregnancies.="" are="" accurate="" predictor="" congenital="" infection.="">