A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

Inclusion Criteria:

   - Diagnosis of primary maternal CMV infection on the basis of one of the following:

      1. A positive CMV Immunoglobulin M (IgM) antibody and low-avidity maternal CMV
      Immunoglobulin G (IgG) antibody screen

      2. Evidence of maternal seroconversion with development of CMV IgG antibody
      following a prior negative CMV screen

   - Gestational age at randomization no later than 23 weeks 6 days based on clinical
   information and evaluation of the earliest ultrasound; or no later than 27 weeks 6
   days for women with a positive IgM, negative IgG initially screened before 23 weeks
   who are rescreened after 2-4 weeks and have evidence of IgG seroconversion.

   - Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or
   therapeutically) before 14 weeks by project gestational age is acceptable.

Exclusion Criteria:

   - Maternal CMV infection pre-dating pregnancy as defined by a high IgG avidity index or
   a positive IgG in the presence of a negative IgM.

   - Known hypersensitivity to plasma or plasma derived products

   - Planned termination of pregnancy

   - Known major fetal anomalies or demise

   - Maternal Immunoglobulin A (IgA) deficiency

   - Planned use of immune globulin, ganciclovir, or valganciclovir

   - Maternal renal disease (most recent pre-randomization serum creatinine ≥ 1.4 mg/dL;
   all women must have serum creatinine measured during the pregnancy and prior to
   randomization)

   - Maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection
   medications)

   - Findings on pre-randomization ultrasound suggestive of established fetal CMV infection
   (cerebral ventriculomegaly, microcephaly, cerebral or intra-abdominal calcifications,
   abnormalities of amniotic fluid volume, echogenic bowel or ascites). Abnormally low
   amniotic fluid volume is defined as no fluid prior to 14 weeks or maximum vertical
   pocket < 2 cm on or after 14 weeks gestation. Abnormally high amniotic fluid volume is
   defined as > 10 cm.

   - Positive fetal CMV findings from culture (amniotic fluid) or PCR.

   - Congenital infection with rubella, syphilis, varicella, parvovirus or toxoplasmosis
   diagnosed by serology and ultrasound or amniotic fluid testing.

   - Intention of the patient or of the managing obstetricians for the delivery to be
   outside a Maternal-Fetal Medicine Units Network (MFMU) Network center

   - Participation in another interventional study that influences fetal or neonatal death

   - Unwilling or unable to commit to 2 year follow-up of the infant