Cytomegalovirus (CMV) Infection in Amniotic Fluid

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by University of Pennsylvania.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194142
First received: September 12, 2005
Last updated: June 6, 2007
Last verified: May 2007
  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: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Estimated Enrollment: 300
Study Start Date: July 2007
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

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194142

Contacts
Contact: Doris Chou, MD 215-662-2982

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Doris Chou, MD    215-662-2982      
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Doris Chou, MD University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00194142     History of Changes
Other Study ID Numbers: 803583, R01 17625-03-14
Study First Received: September 12, 2005
Last Updated: June 6, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Pregnancy
Cytomegalovirus

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

ClinicalTrials.gov processed this record on October 01, 2014