Clinical trial NCT04615715: Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
Official title: Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Cytomegalovirus Infections
Cytomegalovirus Congenital
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-11-04
Enrollment: 840
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Pregnant women will be recruited into the study following their first prenatal visit. After enrollment, they will be randomized to either the CMV risk-reduction intervention or an attention-matched control stress-reduction group stratified by their CMV serostatus.

Women in both groups will attend an individualized behavioral skills session, watch a short video, receive a take-home packet, receive weekly text messages for 12 weeks that reinforce the experimental and control health messages, and attend follow-up visits at 6 and 12 weeks. Saliva, urine, vaginal, and blood specimens will be collected at enrollment and 6 and 12 weeks follow-up visits. Additionally, at-home saliva and vaginal specimen collection will occur at 3 and 9 weeks and once during the third trimester of pregnancy. At delivery, a saliva specimen will be collected from both the mother and infant, along with a remnant cord blood specimen.

Eligibility criteria: 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

Primary outcomes:
measure: CMV seroconversion rate in CMV seronegative women
timeFrame: Enrollment (baseline) until delivery, up to 32 weeks
measure: CMV reinfections in women with non-primary infections
timeFrame: Enrollment(baseline) until delivery, up to 32 weeks
Secondary outcomes:
measure: Change in self-reported CMV risk behaviors and protective behaviors
timeFrame: Enrollment (baseline) to 12 weeks after enrollment (follow-up)
measure: Frequency of CMV shedding
timeFrame: Enrollment(baseline) until delivery, up to 32 weeks
measure: Proportion of infants with congenital CMV
timeFrame: Delivery
measure: Frequency of new CMV variants
timeFrame: Enrollment(baseline) until delivery up to 32 weeks
Other outcomes:
measure: CMV viral loads
timeFrame: Enrollment(baseline) until delivery, up to 32 weeks
measure: Risk factors for CMV infections
timeFrame: Enrollment(baseline) to 12 weeks after enrollment (follow-up)
measure: Change in anxiety after intervention
timeFrame: Enrollment(baseline) to 12 weeks after enrollment (follow-up)
measure: Change in CMV knowledge
timeFrame: Enrollment(baseline) to 12 weeks after enrollment (follow-up)
measure: Acceptability of the educational intervention
timeFrame: Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Karen B Fowler
role: PRINCIPAL_INVESTIGATOR
References: