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Trial record 5 of 156 for:    severe preeclampsia AND Pregnancy Complications

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.
 
ClinicalTrials.gov Identifier: NCT00194155
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date September 12, 2005
First Posted Date September 19, 2005
Last Update Posted Date August 17, 2016
Study Start Date May 2003
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cytomegalovirus (CMV) Infection in Pregnancy
Official Title Cytomegalovirus Infection and Pregnancy Outcomes
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.
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 Observational
Study Design Observational Model: Case-Only
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Pregnancy Complications
  • Cytomegalovirus Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 15, 2016)
283
Original Enrollment
 (submitted: September 12, 2005)
220
Actual Study Completion Date February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Weeks and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00194155
Other Study ID Numbers R01 17625-03-13
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Samuel Parry, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date August 2016