Human Papillomavirus (HPV) Infection in Pregnancy

NCT ID: NCT00194311

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

620 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Papillomavirus Infections Pregnancy Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Principal Investigators

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Samuel Parry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01HD042100-15

Identifier Type: NIH

Identifier Source: secondary_id

View Link

801452

Identifier Type: -

Identifier Source: org_study_id

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