Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy (NCT04615715) | Clinical Trial Compass
CompletedNot Applicable
Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
United States582 participantsStarted 2021-01-11
Plain-language summary
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.
Who can participate
Age range14 Years – 39 Years
SexFEMALE
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Inclusion 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)
Exclusion Criteria:
* 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
What they're measuring
1
CMV seroconversion rate in CMV seronegative women
Timeframe: Enrollment (baseline) until delivery, up to 32 weeks
2
CMV reinfections in women with non-primary infections
Timeframe: Enrollment(baseline) until delivery, up to 32 weeks