Clinical Trial: Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: 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.
Sponsor: Advocate Health Care

Current Primary Outcome: Serum D-dimer levels (ug/ml) [ Time Frame: 18 months ]

Trimester specific D-dimer levels to identify pregnant women at low risk for pulmonary embolism, thereby avoiding radiation exposure


Original Primary Outcome: Same as current

Current Secondary Outcome: Modified Well's Criteria- a risk scoring system for likelihood of pulmonary embolism [ Time Frame: 18 months ]

A Modified Wells score of >4 suggests pulmonary embolism is likely and therefore diagnostic imaging needed


Original Secondary Outcome: Same as current

Information By: Advocate Health Care

Dates:
Date Received: August 19, 2015
Date Started: February 2014
Date Completion:
Last Updated: March 10, 2016
Last Verified: March 2016