Expired Study
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Philadelphia, Pennsylvania 19104


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.


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


Study is Available At:


Original ID:

801452


NCT ID:

NCT00194311


Secondary ID:

R01 HD42100-15


Study Acronym:


Brief Title:

Human Papillomavirus (HPV) Infection in Pregnancy


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

13 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pennsylvania


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

620


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Samuel Parry, MD
Principal Investigator
University of Pennsylvania

Study Dates

Start Date:April 2005
Completion Date:August 2007
Completion Type:Actual
Primary Completion Date:August 2007
Primary Completion Type:Actual
Verification Date:August 2016
Last Changed Date:August 15, 2016
First Received Date:September 13, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:pregnancy complications
Description: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).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pennsylvania
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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