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
- Conditions
- Preeclampsia
- Registration Number
- NCT00572793
- Lead Sponsor
- Carl Weiner, MD
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 431
- Healthy, pregnant females
- Singleton fetus at 7 0/7 to 13 6/7 weeks gestation
- Multi-fetal pregnancy
- Mental retardation
- Known fetal anomaly or demise
- BMI > 35, serious medical condition
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia 37 Weeks
- Secondary Outcome Measures
Name Time Method Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks 34 Weeks, At Delivery
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States