Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709174
• Other study ID #: IRB 5699
• Status: Completed
• Phase: N/A
• First received: August 19, 2015
• Last updated: March 10, 2016
• Start date: February 2014
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Procedure:
• blood draw
blood draw

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No