Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models
- Conditions
- Pulmonary Embolism
- Interventions
- Procedure: blood draw
- Registration Number
- NCT02709174
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pregnant with pulmonary embolism blood draw Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution
- Primary Outcome Measures
Name Time Method Serum D-dimer levels (ug/ml) 18 months Trimester specific D-dimer levels to identify pregnant women at low risk for pulmonary embolism, thereby avoiding radiation exposure
- Secondary Outcome Measures
Name Time Method Modified Well's Criteria- a risk scoring system for likelihood of pulmonary embolism 18 months A Modified Wells score of \>4 suggests pulmonary embolism is likely and therefore diagnostic imaging needed