Overview

This trial is active, not recruiting.

Conditions pregnancy complications, cytomegalovirus infection
Sponsor University of Pennsylvania
Start date May 2003
End date May 2008
Trial size 220 participants
Trial identifier NCT00194155, R01 17625-03-13

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional

Eligibility Criteria

Female participants at least 15 weeks old.

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

Additional Information

Official title Cytomegalovirus Infection and Pregnancy Outcomes
Principal investigator Samuel Parry, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2007.
Information provided to ClinicalTrials.gov by University of Pennsylvania.