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Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus

NCT01819519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2015-06-03

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Infections
  • Pregnancy
  • Behavior

Interventions

BEHAVIORAL

Educational Intervention

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.

Sponsors & Collaborators

Principal Investigators

  • Brenna Anderson, MD · Women & Infants Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01819519 on ClinicalTrials.gov