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Cytomegalovirus (CMV) Infection in Pregnancy
This study is ongoing, but not recruiting participants.
Sponsored by: University of Pennsylvania
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194155
  Purpose

The purpose of this study is to determine if (recurrent) cytomegalovirus (CMV) infection of the mother results in pregnancy complications such as preterm delivery, severe preeclampsia, poor fetal growth, or stillbirth.


Condition
Pregnancy Complications
Cytomegalovirus Infection

MedlinePlus related topics: Cytomegalovirus Infections
U.S. FDA Resources
Study Type: Observational
Study Design: Cross-Sectional, Case Control, Retrospective/Prospective Study
Official Title: Cytomegalovirus Infection and Pregnancy Outcomes

Further study details as provided by University of Pennsylvania:

Estimated Enrollment: 220
Study Start Date: May 2003
Estimated Study Completion Date: May 2008
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, fetal 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.

In this study, we plan to determine if CMV recurrence in the mother results in pregnancy complications. The pregnancy complications listed above have been associated with poor placental function. We also plan to determine if (recurrent) CMV infection in the mother is associated with CMV infection of the placenta.

  Eligibility

Ages Eligible for Study:   15 Weeks and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who deliver at term without pregnancy complications
  • Women who deliver (preterm, less than 37 weeks gestation) as a result of spontaneous preterm labor
  • Women whose pregnancies are complicated by severe preeclampsia
  • Women whose pregnancies are complicated by unexplained poor fetal growth (less than the 10th percentile).
  • Women whose pregnancies are complicated by unexplained stillbirth.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194155

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Samuel Parry, MD University of Pennsylvania
  More Information

Study ID Numbers: R01 17625-03-13
Study First Received: September 12, 2005
Last Updated: August 27, 2007
ClinicalTrials.gov Identifier: NCT00194155  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
cytomegalovirus
pregnancy
placenta

Study placed in the following topic categories:
Virus Diseases
Pregnancy Complications
Pregnancy Complications, Infectious
Cytomegalovirus Infections
DNA Virus Infections
Cytomegalic inclusion disease
Cytomegalovirus
Herpesviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009