NCT02709174

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
Last Updated

October 4, 2024

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

August 19, 2015

Last Update Submit

October 2, 2024

Conditions

Pulmonary Embolism

Keywords

Pulmonary EmbolismPregnancyD-Dimer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Modified Well's Criteria- a risk scoring system for likelihood of pulmonary embolism

    18 months

Study Arms (2)

pregnant with pulmonary embolism

Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution

Procedure: blood draw

pregnant without pulmonary embolism

Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution

Interventions

blood drawPROCEDURE

blood draw

pregnant with pulmonary embolism

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • non-pregnant patients
  • patients \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Barbara Parilla, MD

    Advocate Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2015

First Posted

March 15, 2016

Study Start

February 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 4, 2024

Record last verified: 2016-03