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
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 16 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | November 2007 |
| End Date: | July 2014 |
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
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.
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.
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.
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.
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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