Cytomegalovirus (CMV) Infection in Pregnancy

Pregnancy Complications Clinical Trial

Official title:

Cytomegalovirus Infection and Pregnancy Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194155
• Other study ID #: R01 17625-03-13
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 15, 2016
• Start date: May 2003
• Est. completion date: February 2008

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Weeks and older

Eligibility

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

Observational Model: Case-Only

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infection
• Pregnancy Complications

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States,