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CMV Infection in Amniotic Fluid - Article


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Cmv


Clinical Trial: CMV Infection in Amniotic Fluid

This study is not yet open for patient recruitment.
Verified by University of Pennsylvania September 2005

Sponsored by: University of Pennsylvania
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194142

Purpose

The purpose of this study is to determine if detection of Cytomegalovirus (CMV) in amniotic fluid collected in the second trimester of pregnancy is associated with pregnancy complications such as preterm delivery or severe preeclampsia.
Condition
Pregnancy
Cytomegalovirus

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Cross-Sectional, Case Control, Retrospective/Prospective Study

Further Study Details: 

Expected Total Enrollment:  300

Study start: September 2005

CMV infection in adults with a normal immune system is rarely a serious event. Once a person has been infected with CMV, they may have recurrences (relapses) of the infection. If a mother is infected with the virus or relapses during pregnancy, her fetus may be at risk fo infection. Unlike infection in adults, congenital infection may result in serious complications (congenital infection). The effects of fetal infection with CMV are well understood and many efforts have been made to potentially reduce the risk of congenital infection. However, the effect of CMV infection on the pregnancy itself (when the fetus is not affected by CMV) is less understood.

The incidence of CMV detection in amniotic fluid collected in the second trimester is thought to be low. However, the association between detection of CMV infection in the second trimester and ultimate pregnancy outcome is poorly described.

In this study, we plan to determine if CMV detection in amniotic fluid collected in the second trimester is associated with pregnancy complications.

Eligibility

Ages Eligible for Study:  15 Years   -   45 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

Women who deliver at term without pregnancy complications Women who deliver (preterm, less than 37 weeks gestation) as a result of spontaneous preterm labor Women whose pregnancies are complicated by severe preeclampsia.

Exclusion Criteria:

Women with multi-gestational pregnancies, or whose pregnancies are complicated by a congenital malformations or chromosomal abnormality.

Women who have a medical history of hypertension (high blood pressure), diabetes, or severe renal (kidney) disease

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00194142

Doris Chou, MD      215 662 2982 

Pennsylvania
      Hospital of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
Doris Chou, MD  215-662-2982 

Study chairs or principal investigators

Doris Chou, MD,  Principal Investigator,  University of Pennsylvania   

More Information

Study ID Numbers:  R01 17625-03-14; R01 17625-03-14
Last Updated:  September 16, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00194142
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-20


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Page Updated: June 1, 2005
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