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

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Cytomegalovirus Congenital; Maternal Cytomegalovirus Infections

Treatments: Behavioral: CMV Risk-Reduction Intervention; Behavioral: Stress Reduction Messaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04615715

R01HD098352 (U.S. NIH Grant/Contract)

IRB-300004979

Details and patient eligibility

About

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.

Full 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.

Enrollment: 840 estimated patients

Sex: Female

Ages: 14 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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840 participants in 2 patient groups, including a placebo group

CMV Risk-Reduction Intervention

Experimental group

Description:

One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages

Treatment:

Behavioral: CMV Risk-Reduction Intervention

Stress Reduction Messaging

Placebo Comparator group

Description:

One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages

Treatment:

Behavioral: Stress Reduction Messaging