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Related Publications & Presentations
Objective
To determine the frequency, nature and severity of
congenital defects in infants born to mothers who develop
varicella-zoster virus during pregnancy.
Conclusion
The frequency of clinically significant congenital
varicella zoster virus is very rare in a prospectively
studied population. Vertical transmission of VZV was
rarely detected by serologic tests.
Clinical Centers
Magee Womens, Tennessee, USC, Wayne State, Oklahoma,
Bowman Gray, Cincinnati, Ohio State, South Carolina,
Chicago
Major Eligibility Criteria
- Clinical evidence of varicella virus or clinical episode of
herpes zoster during pregnancy
- Informed consent
Sample Size
Scheduled Evaluations/Data Collection
- Initial Maternal:
- Demographic data, substance and maternal use,
previous and current pregnancy history
- Confirmatory Seriology:
- Anti-VZV-IgG and anti-VZV-IgM 3 weeks after onset
of rash/PCR for VZV DNA
- Antepartum:
- All ultrasounds, amniocenteses and PUBS following
exposure to varicella
- Recommended ultrasound examinations at 16
0- 20
0, 26
0-30
0 and 34
0-36
0 weeks gestation
- Neonatal Serology:
- Cord blood tested for anti-VZV-IgG and anti-
VZV-IGM
- Cord blood of neonates suspected of congenital
infection tested for syphilis, toxoplasma gondii and
cytomegalovirus
- Neonatal urine cultured for cytomegalovirus
- Neonatal:
- Physical exam, neurologic development, ophthalmologic
and auditory evaluation 0-4, 10-14, 22-26 months
Outcome Measures
- Primary:
- Congenital anomaly associated with congenital
varicella syndrome
- Secondary:
- Positive ant-VZV-IgM at delivery
- Effectiveness of antenatal diagnostic procedures
Timetable (as of 9/96)
- Recruitment: 03/93-03/96
- Data Collection: 03/93-05/99
- Closeout/Final Analysis: 05/99-11/99
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