A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)



Status:Active, not recruiting
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any
Updated:2/22/2019
Start Date:April 2012
End Date:August 2021

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Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects.
When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue,
weakness, fever, swollen glands). Most people in the United States are infected during
childhood or as adults if they work around children. Pregnant women, who have not been
infected with CMV in the past and become infected during pregnancy (i.e. a primary
infection), may cause their babies to get infected with CMV. Babies that are infected may
develop permanent disabilities including hearing loss and a small portion will die from the
infection.

Currently it is not routine practice to screen pregnant women for CMV infection.
Additionally, there is no agreement about how to evaluate and manage pregnant women infected
with CMV for the first time. There is also no evidence that treatment is beneficial for the
baby.

The purpose of this research study is to determine whether treating pregnant women who have a
primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.

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 hyperimmune globulin may significantly
reduce the rate of congenital CMV infection following maternal primary infection. The MFMU
CMV Trial will address the primary research question: does maternal administration of CMV
hyperimmune globulin lower the rate of congenital CMV infection among the offspring of women
who have been diagnosed with primary CMV infection during early pregnancy?

The research study is funded by the Eunice Kennedy Shriver National Institutes of Child
Health and Human Development (NICHD). Fourteen medical centers across the country are
participating in this research study. In all, 800 pregnant women who are identified with a
primary CMV infection will be enrolled in this research study. The children of these women
will be evaluated and tested at one and two years of age.

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
We found this trial at
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Ronald Wapner, MD
Phone: 212-305-4348
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Alan T Tita, MD
Phone: 205-996-6262
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: John M Thorp, Jr., MD
Phone: 919-350-6117
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Geeta Swamy, MD
Phone: 919-668-7475
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Ronald Gibbs, MD
Phone: 303-724-6685
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: William Grobman, MD
Phone: 312-503-3200
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Cleveland, Ohio 44109
Principal Investigator: Edward Chien, MD
Phone: 216-778-7533
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Jay Iams, MD
Phone: 614-293-5632
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Brian Casey, MD
Phone: 214-648-2591
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Galveston, Texas 77555
Principal Investigator: George R Saade, MD
Phone: 409-747-1733
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Houston, Texas 77030
Principal Investigator: Baha Sibai, MD
Phone: 713-500-6467
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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69 Brown Street
Providence, Rhode Island 02912
(401) 863-1000
Principal Investigator: Dwight Rouse, MD
Phone: 401-274-1122
Brown University Located in historic Providence, Rhode Island and founded in 1764, Brown University is...
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Salt Lake City, Utah 84132
Principal Investigator: Michael W Varner, MD
Phone: 801-585-7645
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Yasser El-Sayed, MD
Phone: 650-724-6372
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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