Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus

The study is a randomized single-masked clinical trial of behavioral intervention versus
standard care of pregnant women lacking evidence of acute CMV infection that have consented
to be screened as part of the Maternal Fetal Medicine Units Network multi-centered
randomized clinical trial, in which pregnant women are screened with CMV serology for IgM,
IgG, and IgG avidity.

Eligible pregnant women will be randomized to one of two treatment groups:

- Control Group - no intervention

- Intervention Group - brief intervention and educational materials Written informed
consent will be obtained from patients before they can be screened for the study by CMV
testing (IgM, IgG, and IgG avidity) as per the protocol for screening in the MFMU
study.

All women presenting for prenatal care no later than 20 weeks gestational age without a
known multifetal gestation are eligible for CMV screening Those with evidence of primary
infection will be offered participation in the MFMU randomized trial of CMV hyperimmune
globulin to prevent congenital infection. Women lacking evidence of acute infection will be
eligible for randomization into this study. Patients must be randomized no later than 20
weeks gestation.

If eligible and no more than 20 weeks gestation, the patient will be randomized. If the
patient is randomized in the control group, she will continue her routine prenatal care
inclusive of the CDC brochure that she received at the time of her venipuncture for
serologic screening and assessment of hygiene behaviors. If the patient is randomized into
the intervention group, we will deliver a face-face educational intervention during her next
routine prenatal visit. In addition to the intervention, the patient will include
educational material to take home.

Both groups will be assessed for performance of hygiene behaviors as a baseline assessment
at the time of consent. A second assessment will occur at least 12 weeks after enrollment
during the third trimester between 28-36 weeks of gestation. The follow-up assessment will
be completed by a different research assistant from the unblinded educator. A Kessler 10
(K10) survey will also be completed in addition to the baseline and follow-up assessment.

The follow-up assessment will take place during the participant's third trimester between
28-36 weeks of gestation, depending on duration of enrollment and likelihood of early
delivery. The enrollment duration will vary from approximately 14-20 weeks.

Inclusion Criteria:

- Pregnant women lacking evidence of acute CMV infection is defined as one of the
following: A negative IgM antibody (<1.00 Index) and negative IgG antibody (<6.0
AU/ml) or A negative IgM antibody (<1.00 Index) and positive IgG antibody (≥6.0
AU/ml)

- Gestational age during CMV screening will be no later than 20 weeks based on clinical
information and evaluation of the earliest ultrasound.

- Enrollment will occur no later than 20 weeks' gestation.

- Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or
therapeutically) before 20 weeks' by project gestational age is acceptable.

- English and Spanish-speaking women of any age will be offered enrollment

Exclusion Criteria:

- Planned termination of pregnancy

- Women with a previous child with congenital CMV

- Intention of leaving the prenatal practice

- Known major fetal anomalies or demise

- Multiple gestation

- Known HIV infection

- Primary CMV infection, as determined by a positive IgM antibody, a positive IgG
antibody and low IgG avidity or positive IgM antibody and negative IgG antibody

- An old and a recent CMV infection, as determined by a positive IgM antibody, positive
IgG antibody and high IgG avidity.

- Non-Spanish or English speaking