Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

Description

This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.

Conditions

Maternal Cytomegalovirus Infections, Cytomegalovirus Congenital

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Study Overview

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Study Details

Study overview

This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.

Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

Condition
Maternal Cytomegalovirus Infections
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * enrollment in prenatal care before 20 weeks gestation
  • * absence of CMV IgG on serological testing indicating CMV seronegative status or CMV positive (nonprimary) defined as maternal CMV infection pre-dating pregnancy defined by a high IgG avidity index or a positive CMV IgG in the presence of a negative CMV immunoglobulin M (IgM)
  • * known major fetal anomalies or demise
  • * planned termination of pregnancy
  • * planned use of immune globulin, ganciclovir, or valganciclovir
  • * maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection medications)
  • * pre-enrollment ultrasound suggestive of established fetal CMV infection or positive fetal CMV results from culture or PCR
  • * pre-enrollment CMV seroconversion or primary CMV infection in pregnancy
  • * unable to determine if CMV infection is a nonprimary infection due to intermediate or undefined CMV serological test results
  • * pre-enrollment blood, ultrasound, or amniotic fluid testing indicating congenital infection with rubella, syphilis, varicella, parvovirus, toxoplasmosis or other congenital infection
  • * intention of the patient or of the managing obstetricians for the delivery to be outside of the University of Alabama at Birmingham hospital

Ages Eligible for Study

14 Years to 39 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Alabama at Birmingham,

Karen B Fowler, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2025-12-31