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OpenTrials
Completed

NCT Number: NCT00194142

Cytomegalovirus (CMV) Infection in Amniotic Fluid

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.

Completed

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Key information

Age range

15 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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