Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
Completed · Not applicable
Conditions studied: Maternal Cytomegalovirus Infections, Cytomegalovirus Congenital
In brief
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.
Key facts
- Study ID
- NCT04615715
- Run by
- University of Alabama at Birmingham
- People needed
- 582
- Starts
- 2021-01-11
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2026-04-03
Who can join
Age: 14 and older, up to 39. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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