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Clinical trialNCT01376778CompletedPhase 3Interventional

A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

SponsorThe George Washington University Biostatistics CenterEnrollment399Congenital Cytomegalovirus InfectionMaternal Cytomegalovirus Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

16 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama - Birmingham

    Birmingham, Alabama, United States

  • Stanford University

    Stanford, California, United States

  • University of Colorado Denver

    Aurora, Colorado, United States

  • Northwestern University

    Chicago, Illinois, United States

  • Columbia University

    New York, New York, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, United States

  • Duke University

    Durham, North Carolina, United States

  • Case Western Reserve-Metrohealth

    Cleveland, Ohio, United States

  • Ohio State University

    Columbus, Ohio, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • Magee Womens Hospital of Upmc

    Pittsburgh, Pennsylvania, United States

  • Brown University

    Providence, Rhode Island, United States

  • University of Texas - Southwestern Medical Center

    Dallas, Texas, United States

  • University of Texas - Galveston

    Galveston, Texas, United States

  • University of Texas - Houston

    Houston, Texas, United States

  • University of Utah Medical Center

    Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CMV hyperimmune globulin
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2012
Primary completion
31 Oct 2019
Completion
30 Jun 2021
Last update posted
2 Feb 2023
Registered enrollment
399
Registry id
NCT01376778

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.