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
1 other identifier
observational
431
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 8, 2015
July 1, 2015
6.7 years
December 11, 2007
July 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia
37 Weeks
Secondary Outcomes (1)
Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks
34 Weeks, At Delivery
Eligibility Criteria
Pregnant patients seen or referred to the obstetrical clinic
You may qualify if:
- Healthy, pregnant females
- Singleton fetus at 7 0/7 to 13 6/7 weeks gestation
You may not qualify if:
- Multi-fetal pregnancy
- Mental retardation
- Known fetal anomaly or demise
- BMI \> 35, serious medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carl Weiner, MDlead
- Diagnostic Technologies Ltd.collaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Biospecimen
Maternal serum - placental protein 13 level
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl Weiner, MD, MBA
University of Kansas Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor and Chair, Obstetrics and Gynecology
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 13, 2007
Study Start
November 1, 2007
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
July 8, 2015
Record last verified: 2015-07