Maternal Serum Markers Predicting Preeclampsia at Early Gestations

Study Overview
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Brief Summary
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The investigators aim to evaluate a blood test that can identify women at high-risk of PE at the 1st or early 2nd trimester.

Detailed Description
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PE incidence is 5-8% of all pregnancies in US and worldwide. Morbidity, mortality, and medical legal risks of missing PE often lead to over diagnosis. Currently there is no molecular blood laboratory developed test which can allow serial micro-samplings to assess the PE risk when asymptomatic at home setting along the duration of pregnancy. The hypothesis is that a blood test can predict PE with a sensitivity higher than 85% and a specificity higher than 80% at early gestation in a PE-Normal cohort. A single-site retrospective cohort of women who developed PE and women with normal pregnancy will be recruited. Blood samples have been collected from each subject once at the 1st trimester or early 2nd trimester. Delivery and neonatal data have been collected through chart reviews. Two groups (PE and Normal) are matched with age and clinical conditions. It is an observational study of the accuracy of a diagnostic test on PE prediction. There is only one group of participants. Participants will be tested using a blood test to determine positive or negative. Sensitivity and specificity (Primary outcomes) of the test will be measured at the end of study.

Official Title
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A Case-control Study to Investigate Serum Markers in Predicting Preeclampsia

Conditions
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Preeclampsia

Intervention / Treatment
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* Diagnostic Test: Blood test of PE risk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having serum collected at a gestational age between 8 and 21 weeks; Exclusion Criteria: Age less than 18 Preexisting preeclampsia Multiple pregnancy or higher order pregnancy Missing outcome data of PE, including diagnosis date and PE type

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PE group<br>Women with a confirmative diagnosis of PE | Diagnostic Test: Blood test of PE risk<br>* A blood test is applied to women at the 1st or early 2nd trimester to evaluate risk of developing PE<br>|
| Normal pregnancy group<br>Normal pregnant women | Diagnostic Test: Blood test of PE risk<br>* A blood test is applied to women at the 1st or early 2nd trimester to evaluate risk of developing PE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity | Sensitivity and specificity of the blood test in classifying PE and normal | an average of up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity with the sub-cohorts | Sensitivity and specificity of the blood test in classifying PE and normal with the sub-cohorts of a) Early-onset PE, b) Late-onset PE, and c) Severe PE | an average of up to 1 year |