Clincosm LogoSign in Get a demo

Cytomegalovirus (CMV) Infection in Amniotic Fluid

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00194142
Collaborator
(none)
37
Enrollment
1
Location
10
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    37 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Study Start Date :
    Jul 1, 2007
    Actual Primary Completion Date :
    May 1, 2008
    Actual Study Completion Date :
    May 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      15 Years to 45 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

      Sponsors and Collaborators

      • University of Pennsylvania

      Investigators

      • Principal Investigator: Doris Chou, MD, University of Pennsylvania

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of Pennsylvania
      ClinicalTrials.gov Identifier:
      NCT00194142
      Other Study ID Numbers:
      • 803583
      • R01 17625-03-14
      First Posted:
      Sep 19, 2005
      Last Update Posted:
      Aug 17, 2016
      Last Verified:
      Aug 1, 2016
      Keywords provided by University of Pennsylvania
      Pregnancy
      Cytomegalovirus
      Additional relevant MeSH terms:
      Infections
      Cytomegalovirus Infections
      Pregnancy Complications

      Study Results

      No Results Posted as of Aug 17, 2016