A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
IRB#: UNC: 12-0461, Wake: 314660
Cytomegalovirus is a common virus affecting people of all ages and it is estimated that more than half of the people in the U.S. have been infected. Those at greater risk of becoming ill are people with a weakened or compromised immune system such as transplant patients. A newly infected pregnant woman can pass on the virus to a newborn child. CMV can cause serious disease in infants who are infected before birth (congenital CMV infection). About 1 in 150 children are born with congenital CMV infection and about 1 in 5 children born with congenital CMV infection will develop permanent problems such as hearing loss or developmental disabilities.
The purpose of the screening study is to identify pregnant women who have a diagnosis of primary maternal cytomegalovirus (CMV) infection. You can be screened with one additional tube of blood at your prenatal visit, hopefully at the same time your initial prenatal labs are being drawn.
You will only be notified if your screening blood results are positive for CMV antibodies indicating a recent infection (a positive test for recent CMV infection indicate IgM+, IgG+ with a low IgG avidity). Your positive test results will be discussed with you by a member of the research staff. You will be offered to participate in a randomized placebo-controlled study. The study will evaluate whether maternal administration of hyperimmune globulin versus placebo will prevent congenital CMV infection in the infant. Cytogam is an immunoglobulin G (IgG) containing antibodies to CMV. It is made from human plasma. It is indicated in the prophylaxis of CMV disease. Cytogam can raise the relevant antibodies to levels sufficient to reduce the incidence of serious CMV disease.
The women will be given a monthly infusion until delivery. Neonatal saliva and urine samples will be collected for PCR testing of CMV along with liver function test. The infants will be followed at one month for a hearing screen and seen again at 24 months for hearing tests and a developmental test.
You may be qualifed if the following applies to you:
- You have a positive CMV antibody on your screening test
- You are less than 24 weeks pregnant
- You are pregnant with only one baby.
You may not be able to participate if:
- You had CMV prior to your pregnancy
- You are allergic to plasma or plasma products
- You plan to terminate your pregnancy
- Your baby has known serious abnormalities
- You have an IgA deficiency
- You plan to use immune globulin, ganciclovir, or valganciclovir during your pregnancy
- You have renal disease or immune problems
- You have ultrasound findings suggestive of established fetal CMV infection before you are enrolled in the study
- You have positive fetal CMV findings from culture (amniotic fluid) or PCR.
- You have congenital infection with rubella, syphilis, varicella, parvovirus or toxoplasmosis diagnosed by serology and ultrasound or amniotic fluid testing.
- You do not plan to deliver your baby at a MFMU Network Center (UNC or WakeMed)
- You are unwilling or unable to commit to 2 year follow-up of the infant
If you’re not sure if you qualify please contact us so we can help guide you.
Dates of Study
February 2012 to December 2018
This study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Conducted by the NICHD Maternal-Fetal Medicine Units (MFMU). All biostatistical information is the responsibility of the Biostatistical Coordinating Center (BCC) at George Washington University.
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