Cytomegalovirus (CMV) Infection in Pregnancy

Completed

• Conditions: Pregnancy Complications; Cytomegalovirus Infection

• Registration Number: NCT00194155
• Lead Sponsor: University of Pennsylvania

Brief 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.

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.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 283

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States