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©2022 Stanford Medicine
Trial ID: NCT01376778
A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery
- 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.
- 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
- Maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection
- 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
drug: CMV hyperimmune globulin
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Dr. Yasser El-Sayed