Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection
- Conditions
- Disorder of Cardiac Function
- Interventions
- Device: echocardiographic examination
- Registration Number
- NCT02787382
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief Summary
BACKGROUND
Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral or autoimmune etiologies. Human CMV represents one of the leading causes of congenital infections worldwide. There is limited data regarding the cardiac function of fetuses and infants with CMV.
OBJECTIVE
To provide insight regarding the presence of myocardial involvement in fetuses and infants with CMV infection.
PATIENTS \& METHODS
Up to 100 fetuses with suspected CMV infection will be enrolled during a 3 years period. Patients will undergo detailed US examinations including dedicated neurosonography and echocardiography starting at the time of the first referral and every 3-4 weeks until delivery and at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy women from the group will serve as controls
- Detailed Description
BACKGROUND
Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral or autoimmune etiologies. Human CMV represents one of the leading causes of congenital infections worldwide. There is limited data regarding the cardiac function of fetuses and infants with CMV.
OBJECTIVE
To provide insight regarding the presence of myocardial involvement in fetuses and infants with CMV infection.
PATIENTS \& METHODS
Up to 100 fetuses with suspected CMV infection will be enrolled during a 3 years period. Patients will undergo detailed US examinations including dedicated neurosonography and echocardiography starting at the time of the first referral and every 3-4 weeks until delivery and at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy women from the group will serve as controls
EXPECTED RESULTS
Subtle myocardial deformation abnormalities are expected to be commonly found in fetuses and infants with CMV infection.
CONCLUSIONS
The findings of this present study will underscore the need for cardiac screening of fetuses and infants with congenital CMV infection, with long-term follow-up to document the natural history and disease burden of CMV in this population.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- Patients referred because of suspected CMV IUI as demonstrated by seroconversion during pregnancy or during the 3 months that precede LMP or
- Patients referred because of suspected CMV IUI based on the presence borderline CMV serology
- US signs indicative of intrauterine CMV infection (CNS and non CNS involvement).
- Multifetal pregnancy.
- Pregnant women planning to deliver elsewhere who are offered yet refuse to participate in the postnatal investigation following discharge from the hospital.
- Patients will be excluded if they had clinical heart failure, as defined by the New York Heart Association classification (NYHA, class II-IV) (Criteria committee of NYHA 1994), a history of cardiovascular disease or chronic renal insufficiency.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pregnant women with CMV infection echocardiographic examination An attempt to record the fetal myocardium will be done at the initial examination and at all the follow up examinations performed during pregnancy (every 3-4 weeks according to the clinical protocol currently in use at the OB-GYN US Unit). The participants will undergo a detailed fetal echocardiography according to standard guidelines (see below, section echocardiography). Pregnant women with suspected CMV infection echocardiographic examination The healthy women from the group will serve as controls. An attempt to record the fetal myocardium will be done at the initial examination and at all the follow up examinations performed during pregnancy (every 3-4 weeks according to the clinical protocol currently in use at the OB-GYN US Unit). The participants will undergo a detailed fetal echocardiography according to standard guidelines (see below, section echocardiography). As the control group-Newborns found to be negative for CMV will serve as control group.
- Primary Outcome Measures
Name Time Method diastolic strain RATE 5 month US test will measure diastolic strain RATE (will be measured by %)
systolic strain RATE 5 month US test will measure systolic strain RATE (will be measured by %)
- Secondary Outcome Measures
Name Time Method