Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Procedure: blood draw

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.

• Study Type: Observational
• Enrollment (Actual): 59

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant women who presented to the Emergency Department or Labor and Delivery unit with signs and symptoms suspicious for PE

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pregnant with pulmonary embolism; Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution	Procedure: blood draw; blood draw
pregnant without pulmonary embolism; 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

Collaborators and Investigators

• Sponsor: Advocate Health Care

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Estimate): March 15, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Pregnancy; D-Dimer; Pulmonary Embolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: IRB 5699