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Cytomegalovirus (CMV) Infection in Amniotic Fluid

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00194142
First Posted: September 19, 2005
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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
Pregnancy Complications Cytomegalovirus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Enrollment: 37
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The purpose of this study is to determine the prevalence of Cytomegalovirus (CMV) infection in amniotic fluid specimens obtained at 16 to 18 weeks of pregnancy and to determine if CMV infection of amniotic fluid supernatant and/or amniocytes is associated with adverse obstetric outcomes. Amniotic fluid will be obtained from an already established registry. and analyzed in conjunction with a chart review under a HIPAA Waiver of Authorization.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194142


Locations
United States, Pennsylvania
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
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194142     History of Changes
Other Study ID Numbers: 803583
R01 17625-03-14
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by University of Pennsylvania:
Pregnancy
Cytomegalovirus

Additional relevant MeSH terms:
Infection
Cytomegalovirus Infections
Pregnancy Complications
Herpesviridae Infections
DNA Virus Infections
Virus Diseases