Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pregnant with pulmonary embolism

Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution

blood draw

Intervention Type PROCEDURE

blood draw

pregnant without pulmonary embolism

Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution

No interventions assigned to this group

Interventions

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blood draw

Intervention Type PROCEDURE

Eligibility Criteria

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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