NCT00194311

Brief Summary

The purpose of this study is to determine if maternal infection with human papillomavirus (HPV) is associated with pregnancy complications including spontaneous preterm delivery (sPTD), severe preeclampsia (PE), and poor fetal growth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Typical duration 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

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

August 15, 2016

Conditions

Papillomavirus InfectionsPregnancy Complications

Keywords

HPVPregnancy

Study Arms (1)

pregnancy complications

prospective cohort study is to determine if maternal infection with Human papillomavirus (HPV) is associated with pregnancy complications including spontaneous preterm delivery (sPTD), severe preeclampsia (PE) (as per current ACOG: American College of Obstetrics and Gynecology criteria), and intrauterine growth restriction (IUGR).

Eligibility Criteria

Age13 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All women presenting for prenatal care at the Hospital of the University of Pennsylvania or affiliated clinics

You may not qualify if:

  • Multiple gestations
  • Medical conditions such as diabetes, chronic hypertension, renal disease
  • Fetal malformations or chromosomal anomalies
  • Fetal death

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

Papillomavirus InfectionsPregnancy Complications

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Samuel Parry, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

April 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

US(1)