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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

Sponsor
Carl Weiner, MD (Other)
Overall Status
Completed
CT.gov ID
NCT00572793
Collaborator
Diagnostic Technologies Ltd. (Industry)
431
Enrollment
1
Location
80
Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    431 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    A Nested Case-Controlled Study Evaluating the Utility of Placental Protein 13 (PP13) In-vitro Diagnostic Kit as a Diagnostic Aiding Tool in Assessment of the Risk for Developing Preeclampsia Necessitating Delivery Before 37 Weeks (Early-preeclampsia) Based on First Trimester Blood Testing of Pregnant Women With Low and Unknown Risk
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    Jul 1, 2014
    Actual Study Completion Date :
    Jul 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia [37 Weeks]

    Secondary Outcome Measures

    1. Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks [34 Weeks, At Delivery]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160

    Sponsors and Collaborators

    • Carl Weiner, MD
    • Diagnostic Technologies Ltd.

    Investigators

    • Principal Investigator: Carl Weiner, MD, MBA, University of Kansas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carl Weiner, MD, Professor and Chair, Obstetrics and Gynecology, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT00572793
    Other Study ID Numbers:
    • 11063
    First Posted:
    Dec 13, 2007
    Last Update Posted:
    Jul 8, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Pre-Eclampsia

    Study Results

    No Results Posted as of Jul 8, 2015