Status:
COMPLETED
Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Cytomegalovirus Infections
Pregnancy
Eligibility:
FEMALE
14-45 years
Phase:
NA
Brief 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 t...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01819519
Start Date
March 1 2013
End Date
March 1 2015
Last Update
June 3 2015
Active Locations (1)
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1
Women and Infants Hospital
Providence, Rhode Island, United States, 02905