Pulmonary EmbolismNCT02709174
Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models
An observational study of Pulmonary Embolism, run by Wake Forest University Health Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women who presented to the Emergency Department or Labor and Delivery unit with signs and symptoms suspicious for PE
Who may be able to join
- 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
Who cannot join
- non-pregnant patients
- patients < 18 years old
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- blood draw
- Keywords
- Pulmonary Embolism, Pregnancy, D-Dimer
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawProcedure or surgery
blood draw
| Study group | Role | What they receive |
|---|---|---|
| pregnant with pulmonary embolism | Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution Receives: Procedure: blood draw | |
| pregnant without pulmonary embolism | Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (1)
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Parilla, MD, Principal investigator, Advocate Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709174
- Sponsor's protocol ID
- IRB 5699
- Status last verified
- Mar 2016
- First submitted
- 19 Aug 2015
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Pulmonary Embolism in Pregnancy: Are Biomarkers and Clinical Prediction Models Useful?
- ClinicalTrials.gov ID
- NCT02709174
- Acronym / sponsor ID
- IRB 5699
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Pregnancy, D-Dimer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant with pulmonary embolism | – | Procedure: blood drawPregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution |
| pregnant without pulmonary embolism | – | –Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women who presented to the Emergency Department or Labor and Delivery unit with signs and symptoms suspicious for PE
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- non-pregnant patients
- patients < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawblood draw | Procedure or surgery | pregnant with pulmonary embolism |
Primary outcome
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
1 secondary outcome
Modified Well's Criteria- a risk scoring system for likelihood of pulmonary embolism
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Parilla, MD principal investigator
Advocate Health
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum D-dimer levels (ug/ml) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.