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

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. Identifier: NCT00572793
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : July 8, 2015
Diagnostic Technologies Ltd.
Information provided by (Responsible Party):
Carl Weiner, MD, University of Kansas Medical Center

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

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 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 : November 2007
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Carl Weiner, MD, Professor and Chair, Obstetrics and Gynecology, University of Kansas Medical Center Identifier: NCT00572793     History of Changes
Other Study ID Numbers: 11063
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications