- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00194311
Human Papillomavirus (HPV) Infection in Pregnancy
August 15, 2016 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
620
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Samuel Parry, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
August 17, 2016
Last Update Submitted That Met QC Criteria
August 15, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 801452
- R01HD042100-15 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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