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Recruiting
I'm InterestedTrial 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
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
drug: CMV hyperimmune globulin
other: Placebo
Recruiting
I'm Interested
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Dr. Yasser El-Sayed
650 725-8623