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Cytomegalovirus (CMV) Infection in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00194155
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 17, 2016
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 283 participants
Observational Model: Case-Only
Official Title: Cytomegalovirus Infection and Pregnancy Outcomes
Study Start Date : May 2003
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Weeks and older   (Child, Adult, Older Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00194155

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

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Responsible Party: University of Pennsylvania Identifier: NCT00194155    
Other Study ID Numbers: R01 17625-03-13
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Keywords provided by University of Pennsylvania:
Additional relevant MeSH terms:
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Communicable Diseases
Cytomegalovirus Infections
Pregnancy Complications
Herpesviridae Infections
DNA Virus Infections
Virus Diseases