A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

Launched by THE GEORGE WASHINGTON UNIVERSITY BIOSTATISTICS CENTER · Jun 16, 2011

Keywords

ClinConnect Summary

Cytomegalovirus (CMV) is the most common congenital infection, with approximately 44,000 congenitally infected infants in the U.S. per year. A substantial proportion of these infants will die or suffer permanent injury as a result of their infection. The severity of congenital infection is greatest with primary maternal CMV infection. Currently, there is no proven method of preventing congenital CMV infection, and the approach to primary maternal CMV infection in the United States is haphazard and ineffective. One small, non-randomized study suggests that maternal administration of CMV hype...

Gender

FEMALE

Eligibility criteria

• 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