Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models

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.

Completed

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Procedure

blood draw

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 15, 2016
Registry last updated: Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed