Cytomegalovirus (CMV) Infection in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194155
First received: September 12, 2005
Last updated: August 27, 2007
Last verified: August 2007
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cytomegalovirus Infection and Pregnancy Outcomes

Resource links provided by NLM:


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
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: 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

No publications provided

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

Keywords provided by University of Pennsylvania:
cytomegalovirus
pregnancy
placenta

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

ClinicalTrials.gov processed this record on July 20, 2014