ACTIVE_NOT_RECRUITING

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

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Conditions

Maternal Cytomegalovirus InfectionsCytomegalovirus Congenital

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-01-11
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04615715

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.

Ages Eligible for Study:14 Years to 39 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * enrollment in prenatal care before 20 weeks gestation
  2. * 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)
  1. * known major fetal anomalies or demise
  2. * planned termination of pregnancy
  3. * planned use of immune globulin, ganciclovir, or valganciclovir
  4. * maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection medications)
  5. * pre-enrollment ultrasound suggestive of established fetal CMV infection or positive fetal CMV results from culture or PCR
  6. * pre-enrollment CMV seroconversion or primary CMV infection in pregnancy
  7. * unable to determine if CMV infection is a nonprimary infection due to intermediate or undefined CMV serological test results
  8. * pre-enrollment blood, ultrasound, or amniotic fluid testing indicating congenital infection with rubella, syphilis, varicella, parvovirus, toxoplasmosis or other congenital infection
  9. * intention of the patient or of the managing obstetricians for the delivery to be outside of the University of Alabama at Birmingham hospital

Contacts and Locations

Principal Investigator

Karen B Fowler
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Karen B Fowler, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-11
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-01-11
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Maternal Cytomegalovirus Infections
  • Cytomegalovirus Congenital