Cytomegalovirus (CMV) Infection in Amniotic Fluid

Completed

• Conditions: Cytomegalovirus Infections; Pregnancy Complications

• Registration Number: NCT00194142
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Start: 2007-07
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States