- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00194155
Cytomegalovirus (CMV) Infection in Pregnancy
Cytomegalovirus Infection and Pregnancy Outcomes
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samuel Parry, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01 17625-03-13
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