Cytomegalovirus (CMV) Infection in Pregnancy

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00194155

Collaborator

(none)

283

Enrollment

Location

57.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Complications Cytomegalovirus Infection

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 Design

Study Type:

Observational

Actual Enrollment :

283 participants

Observational Model:

Case-Only

Official Title:

Cytomegalovirus Infection and Pregnancy Outcomes

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Weeks and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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