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Human Papillomavirus (HPV) Infection in Pregnancy

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194311
First received: September 13, 2005
Last updated: August 15, 2016
Last verified: August 2016
  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

Ages Eligible for Study:   13 Years to 45 Years   (Child, Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 13, 2005
Last Updated: August 15, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
HPV
Pregnancy

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

ClinicalTrials.gov processed this record on September 30, 2016