Viewing Study NCT00194142



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Last Modification Date: 2024-10-26 @ 9:17 AM
Study NCT ID: NCT00194142
Status: COMPLETED
Last Update Posted: 2016-08-17
First Post: 2005-09-12

Brief Title: Cytomegalovirus CMV Infection in Amniotic Fluid
Sponsor: University of Pennsylvania
Organization: University of Pennsylvania

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2016-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01 17625-03-14 None None None