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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572793
First Posted: December 13, 2007
Last Update Posted: July 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Diagnostic Technologies Ltd.
Information provided by (Responsible Party):
Carl Weiner, MD, University of Kansas Medical Center Research Institute
December 11, 2007
December 13, 2007
July 8, 2015
November 2007
July 2014   (Final data collection date for primary outcome measure)
Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia [ Time Frame: 37 Weeks ]
Same as current
Complete list of historical versions of study NCT00572793 on ClinicalTrials.gov Archive Site
Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks [ Time Frame: 34 Weeks, At Delivery ]
Same as current
Not Provided
Not Provided
 
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
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
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Maternal serum - placental protein 13 level
Non-Probability Sample
Pregnant patients seen or referred to the obstetrical clinic
Preeclampsia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
431
July 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
16 Years to 45 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00572793
11063
No
Not Provided
Not Provided
Carl Weiner, MD, University of Kansas Medical Center Research Institute
Carl Weiner, MD
Diagnostic Technologies Ltd.
Principal Investigator: Carl Weiner, MD, MBA University of Kansas Medical Center
University of Kansas Medical Center
July 2015