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A Study to Evaluate the Use of Placenta Protein 13 (PP13) in the First Trimester of Pregnancy as a Diagnostic Aiding Tool in the Assessment of the Risk for Developing Preeclampsia in Women With Low and Unknown Risk

NCT ID: NCT00572793

Last Updated: 2015-07-08

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

431 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to evaluate whether it is possible to detect changes in the concentration of PP13 in the blood of pregnant women who may go on to develop the complication of preeclampsia later on in the pregnancy, and if these changes can be detected early enough to allow early diagnosis and treatment for prevention of these complications and reduce their damage. This study will test if the PP13 biomarker during the first trimester of pregnancy has the ability to provide assessment of risk for the development of preeclampsia that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34 weeks gestation.

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Detailed Description

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After obtaining informed consent maternal demographics, vital signs, height, weight, medical history, pregnancy dating, dipstick for urine protein, previous lab results, nuchal translucency results and uterine artery Doppler results (if done) will be obtained. Blood for PP13 will be obtained at 7-13 weeks and optionally at 21-23 weeks. Hospitalization and delivery information will be obtained via a chart review for evidence of preeclampsia.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Healthy, pregnant females
* Singleton fetus at 7 0/7 to 13 6/7 weeks gestation

Exclusion Criteria

* Multi-fetal pregnancy
* Mental retardation
* Known fetal anomaly or demise
* BMI \> 35, serious medical condition
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Diagnostic Technologies Ltd.

INDUSTRY

Sponsor Role collaborator

Carl Weiner, MD

OTHER

Sponsor Role lead

Responsible Party

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Carl Weiner, MD

Professor and Chair, Obstetrics and Gynecology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carl Weiner, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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11063

Identifier Type: -

Identifier Source: org_study_id

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