NCT00194155

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
283

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2003

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

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
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

4.8 years

First QC Date

September 12, 2005

Last Update Submit

August 15, 2016

Conditions

Pregnancy ComplicationsCytomegalovirus Infection

Keywords

cytomegaloviruspregnancyplacenta

Eligibility Criteria

Age15 Weeks+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

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

  • Samuel Parry, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

May 1, 2003

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

US(1)