NCT00194142

Brief Summary

The purpose of this study is to determine if detection of cytomegalovirus (CMV) in amniotic fluid collected in the second trimester of pregnancy is associated with pregnancy complications such as preterm delivery or severe preeclampsia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

September 12, 2005

Last Update Submit

August 15, 2016

Conditions

Pregnancy ComplicationsCytomegalovirus Infections

Keywords

PregnancyCytomegalovirus

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The purpose of this study is to determine the prevalence of Cytomegalovirus (CMV) infection in amniotic fluid specimens obtained at 16 to 18 weeks of pregnancy and to determine if CMV infection of amniotic fluid supernatant and/or amniocytes is associated with adverse obstetric outcomes. Amniotic fluid will be obtained from an already established registry. and analyzed in conjunction with a chart review under a HIPAA Waiver of Authorization.

You may qualify if:

  • Women who deliver at term without pregnancy complications
  • Women who deliver (preterm, less than 37 weeks of gestation) as a result of spontaneous preterm labor
  • Women whose pregnancies are complicated by severe preeclampsia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pregnancy ComplicationsCytomegalovirus Infections

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Doris Chou, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

US(1)