A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

Description

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.

Study Start Date

April 2012

Estimated Completion Date

December 2018

Interventions

  • Drug: CMV hyperimmune globulin

Specialties

  • Obstetrics & Gynecology: Maternal Fetal Medicine,Obstetrics,Preventive Medicine,STDs/Infections
  • Infectious Disease: OB/TORCH Infections

MeSH Terms

  • Cytomegalovirus
  • Cytomegalovirus Infections

Study ID

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) -- HD36801-CMV

Status

Unknown

Trial ID

NCT01376778

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

800

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Inclusion Criteria

  • Diagnosis of primary maternal CMV infection on the basis of one of the following: 1. A positive CMV IgM antibody and low-avidity maternal CMV 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 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 ascities). 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 MFMU Network center
  • Participation in another interventional study that influences fetal or neonatal death
  • Participation in this trial in a previous pregnancy
  • Unwilling or unable to commit to 2 year follow-up of the infant

Gender

Female

Ages

N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (13)

Study Location Distance Name Phone Email
Brown University - Providence, Rhode Island 42.6 miles Donna Allard RNC 401-274-1122 dallard@wihri.org
Columbia University - New York, New York 181.2 miles Sabine Bousleiman 212-305-4348 sb1080@columbia.edu
Case Western ReserveMetrohealth - Cleveland, Ohio 549.6 miles Wendy Dalton RN 216-778-7533 wdalton@metrohealth.org
Duke University - Durham, North Carolina 609.0 miles Tammy Sinclair Bishop RN 919-668-7475 sincl008@mc.duke.edu
University of North Carolina Chapel Hill - Chapel Hill, North Carolina 616.4 miles Kelly Clark RN 919-350-6117 kelly_clark@med.unc.edu
Ohio State University - Columbus, Ohio 641.8 miles Francee Johnson RN 614-293-5632 johnson.126@osu.edu
Northwestern University - Chicago, Illinois 847.9 miles Gail Mallett BSN 312-503-3200 g-mallett@northwestern.edu
University of Alabama Birmingham - Birmingham, Alabama 1,051.7 miles Stacy Harris BSN 205-996-6262 stacylharris@uabmc.edu
University of Texas Southwestern Medical Center - Dallas, Texas 1,551.5 miles Lisa Moseley RN 214-648-2591 lisa.moseley@utsouthwestern.edu
University of Texas Galveston - Galveston, Texas 1,599.3 miles Ashley Salazar MSN 409-747-1733 assalaza@utmb.edu
University of Texas Houston - Houston, Texas 1,609.9 miles Felecia Ortiz RN 713-500-6467 Felecia.Ortiz@uth.tmc.edu
University of Colorado Denver - Aurora, Colorado 1,759.8 miles Kathy Hale BSN 303-724-6685 Kathy.A.Hale@ucdenver.edu
University of Utah Medical Center - Salt Lake City, Utah 2,094.1 miles Kim Hill RN 801-585-7645 Kim.Hill@hsc.utah.edu

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