Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus

Completed · Not applicable

Conditions studied: Cytomegalovirus Infections, Pregnancy, Behavior

In brief

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.

Key facts

Study ID

NCT01819519

Run by

Women and Infants Hospital of Rhode Island

People needed

223

Starts

2013-03-01

Expected to finish

2015-03-01

Last updated by the study team

2015-06-03

Who can join

Age: 14 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Women and Infants Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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