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Cytomegalovirus (CMV) Infection in Amniotic Fluid

This study has been completed.
Information provided by (Responsible Party):
University of Pennsylvania Identifier:
First received: September 12, 2005
Last updated: August 15, 2016
Last verified: August 2016
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.

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.


Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Genders 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.

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 identifier: NCT00194142

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: Doris Chou, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania Identifier: NCT00194142     History of Changes
Other Study ID Numbers: 803583  R01 17625-03-14 
Study First Received: September 12, 2005
Last Updated: August 15, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Additional relevant MeSH terms:
Pregnancy Complications
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases processed this record on October 25, 2016