Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate whether trimester specific d-dimer levels and brain natriuretic protein (BNP), along with the modified Wells score (MWS), is a useful risk stratification tool to exclude pregnant women at low-risk of pulmonary embolism (PE) from diagnostic imaging with radiation exposure.

Detailed Description
-----------------
To account for all women meeting the study eligibility criteria, this study utilized a combined prospective and retrospective arm. Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution were prospectively enrolled from February 2014 to August 2015. Both d-dimer and BNP serum levels were drawn, and a MWS was assigned. All pregnant women diagnosed with a PE that underwent diagnostic imaging and had a d-dimer level drawn from January 2009 to June 2014 were retrospectively enrolled. Patient electronic records were used to apply the MWS and analyze their risk.

Official Title
-----------------
Diagnosing Pulmonary Embolism in Pregnancy: Are Biomarkers and Clinical Prediction Models Useful?

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Procedure: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: adult pregnant women >= 18 years old d-dimer obtained and if the patient was pregnant at the time of PE diagnosis patient presented to the Emergency Department or Labor and Delivery unit patient presented with signs and symptoms suspicious for PE Exclusion criteria: non-pregnant patients patients < 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant with pulmonary embolism<br>Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution | Procedure: blood draw<br>* blood draw<br>|
| pregnant without pulmonary embolism<br>Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum D-dimer levels (ug/ml) | Trimester specific D-dimer levels to identify pregnant women at low risk for pulmonary embolism, thereby avoiding radiation exposure | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Well's Criteria- a risk scoring system for likelihood of pulmonary embolism | A Modified Wells score of >4 suggests pulmonary embolism is likely and therefore diagnostic imaging needed | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Embolism, Pregnancy, D-Dimer