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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.
Diagnostic Technologies Ltd.
Information provided by (Responsible Party):
Carl Weiner, MD, University of Kansas Medical Center Research Institute Identifier:
First received: December 11, 2007
Last updated: July 7, 2015
Last verified: July 2015
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.


Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia [ Time Frame: 37 Weeks ]

Secondary Outcome Measures:
  • Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks [ Time Frame: 34 Weeks, At Delivery ]

Biospecimen Retention:   Samples Without DNA
Maternal serum - placental protein 13 level

Enrollment: 431
Study Start Date: November 2007
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients seen or referred to the obstetrical clinic

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
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Please refer to this study by its identifier: NCT00572793

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Carl Weiner, MD
Diagnostic Technologies Ltd.
Principal Investigator: Carl Weiner, MD, MBA University of Kansas Medical Center
  More Information

Responsible Party: Carl Weiner, MD, Professor and Chair, Obstetrics and Gynecology, University of Kansas Medical Center Research Institute Identifier: NCT00572793     History of Changes
Other Study ID Numbers: 11063
Study First Received: December 11, 2007
Last Updated: July 7, 2015

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications processed this record on May 23, 2017