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Human Papillomavirus (HPV) Infection in Pregnancy

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00194311
Collaborator
National Institutes of Health (NIH) (NIH)
620
Enrollment
1
Location
28
Duration (Months)
22.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    620 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Apr 1, 2005
    Actual Primary Completion Date :
    Aug 1, 2007
    Actual Study Completion Date :
    Aug 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      13 Years to 45 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00194311
      Other Study ID Numbers:
      • 801452
      • R01HD042100-15
      First Posted:
      Sep 19, 2005
      Last Update Posted:
      Aug 17, 2016
      Last Verified:
      Aug 1, 2016
      Keywords provided by , ,
      HPV
      Pregnancy
      Additional relevant MeSH terms:
      Infections
      Papillomavirus Infections
      Pregnancy Complications

      Study Results

      No Results Posted as of Aug 17, 2016