Cytomegalovirus (CMV) Infection in Amniotic Fluid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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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 for 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.

Conditions

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Pregnancy Complications Cytomegalovirus Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Women who deliver at term without pregnancy complications
* Women who deliver (preterm, less than 37 weeks of 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 malformation or chromosomal abnormality
* Women who have a medical history of hypertension (high blood pressure), diabetes, or severe renal (kidney) disease

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No