Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus
Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus
The purpose of this study is to develop a brief screening and behavioral intervention for the
 prevention of congenital cytomegalovirus (CMV) that will both be acceptable to clinic staff
 and feasible to implement as part of routine clinical prenatal care, and to test whether
 behavioral intervention for susceptible pregnant women can lead to a behavioral change that
 is likely to lead to decreased primary CMV infection. The study research assistants will
 enroll pregnant women who are less than 20 weeks' gestation, either English or
 Spanish-speaking and that do not have a primary CMV infection (never been infected or
 previously infected). Enrollment will occur during the woman's prenatal visit.
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