Cytomegalovirus (CMV) Infection in Amniotic Fluid

Pregnancy Complications Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194142
• Other study ID #: 803583
• Secondary ID: R01 17625-03-14
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 15, 2016
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Infection
• Pregnancy Complications

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States,