Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus
Condition: Cytomegalovirus Infections; Pregnancy; Behavior
MeSH terms: Cytomegalovirus Infections
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Educational Intervention
Intervention type(s): Behavioral
Intervention description(s): The patient will told if previously infected or seronegative and what is the risk of the becoming infected. The research assistant will deliver a 5-10 minutes educational intervention, which will consist of a CMV video and some Q&A.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Intervention studies; Pregnancy; Cytomegalovirus Infections