Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02709174

Enrollment

Registered

2016-03-15

Start date

2014-02-28

Completion date

2015-08-31

Last updated

2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism, Pregnancy, D-Dimer

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.

Interventions

PROCEDUREblood draw

blood draw

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026