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

Preeclampsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572793
• Other study ID #: 11063
• Status: Completed
• Phase: N/A
• First received: December 11, 2007
• Last updated: July 7, 2015
• Start date: November 2007
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Carl Weiner, MD	Diagnostic Technologies Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia		37 Weeks	No
Secondary	Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks		34 Weeks, At Delivery	No