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Cytomegalovirus (CMV) Infection in Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194155
First received: September 12, 2005
Last updated: August 15, 2016
Last verified: August 2016
  Purpose
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
Pregnancy Complications
Cytomegalovirus Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Cytomegalovirus Infection and Pregnancy Outcomes

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Enrollment: 283
Study Start Date: May 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Weeks and older   (Child, Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will use already collected clinical samples in order to test for cytomegalovirus (CMV), in order to determine whether CMV is associated with pregnancy complications that are attributed to placental dysfunction. The subject population will include women diagnosed with preeclampsia, intrauterine fetal demise, intrauterine growth restriction, and spontaneous pre-term delivery. There will also be healthy controls.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194155

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Samuel Parry, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194155     History of Changes
Other Study ID Numbers: R01 17625-03-13 
Study First Received: September 12, 2005
Last Updated: August 15, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
cytomegalovirus
pregnancy
placenta

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cytomegalovirus Infections
Pregnancy Complications
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 23, 2016