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Human Papillomavirus (HPV) Infection in Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00194311
First Posted: September 19, 2005
Last Update Posted: August 17, 2016
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Pennsylvania
  Purpose
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.

Condition
Papillomavirus Infections Pregnancy Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Pennsylvania:

Estimated Enrollment: 620
Study Start Date: April 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Multiple gestations
  • Medical conditions such as diabetes, chronic hypertension, renal disease
  • Fetal malformations or chromosomal anomalies
  • Fetal death
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00194311


Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
Investigators
Principal Investigator: Samuel Parry, MD University of Pennsylvania
  More Information

ClinicalTrials.gov Identifier: NCT00194311     History of Changes
Other Study ID Numbers: 801452
R01HD042100-15 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 19, 2005
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by University of Pennsylvania:
HPV
Pregnancy

Additional relevant MeSH terms:
Infection
Pregnancy Complications
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections