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Title
CMV in Pregnancy Study

Formal Study Name
A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

Organization
Women & Infants

Research Type
Clinical

Primary Principal Investigator

Additional Principal Investigator

Area of Study
Pregnancy


Eligibility Criteria
  • Screen positive for CMV.
  • Enrolled at less than 24 weeks.
  • No evidence of CMV already present on fetal scan.

Recruitment Status
Open

Recruitment End Date
03/29/2016

Study Start Date
03/29/2012

Study End Date
03/29/2019

Description

This is a randomized double blinded placebo control trial in which women who have tested positive for CMV in the early pregnancy may receive monthly infusions of either placebo or Cytogam (antibodies to CMV) in hopes that it will either stop or decrease the incidence of transmission to the fetus and its sequelae.

See study details on ClinicalTrials.gov

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Contact Information
Donna Allard, MFMU research manager, at (401) 274-1122, ext. 48522.

Compensation/Reimbursement

Patients receive $100 at each monthly study infusion and at the one and two year infant follow- ups.


More Information/FAQ

CMV is common virus spread like a cold or flu. If a woman is infected for the first time while pregnant, there is a 40 percent chance the fetus will also be infected. These fetuses are more likely to be born earlier, have low birth weight, or smaller heads. Some of these babies will develop problems such as hearing loss and learning disabilities. There is currently no approved treatment for CMV.