Pulmonary EmbolismNCT00771303
Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
An observational study of Pulmonary Embolism and Deep Vein Thrombosis, run by University Hospital, Geneva at 9 sites in 2 countries.
Trial summary
Venous thromboembolism (VTE) remains a major cause of maternal morbidity and mortality in developed countries. Objective diagnosis of pulmonary embolism (PE) and/or deep vein thrombosis (DVT) in pregnancy is crucial. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis
- What is being tested?
- Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT.
- How many people
- 402 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Sep 2008to Aug 2017
- 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 with suspected PE.
Who may be able to join
- All pregnant patients with a clinical suspicion of acute PE will be included in the study, provided they correspond to the following diagnostic and exclusion criteria, and they have signed an informed consent form.
Who cannot join
- Age less than 18 years
- Absence of informed consent
- Patients allergic to contrast medium
- Impaired renal function (creatine clearance less than 30 ml/min as estimated by the Cockroft formula)
- Geographic inaccessibility for follow-up
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
France8 sites
Pierre-Marie ROY
Angers, 49933
Grégoire LE GAL
Brest, 29609
Florence PARENT
Clamart, 92141
Isabelle QUERE
Montpellier, 34295
Jean-Christophe GRIS
Nîmes, 30029
Guy MEYER
Paris, 75015
Caroline BOHEC
Pau, 64000
Antoine ELIAS
Toulon, 83056
About this study
Venous thromboembolism (VTE) remains a major cause of maternal morbidity and mortality in developed countries. Objective diagnosis of pulmonary embolism (PE) and/or deep vein thrombosis (DVT) in pregnancy is crucial. Failure to identify PE or/or DVT will place the mother's life at risk, and unnecessary treatment will not only expose her to anticoagulants but will also label her as having had VTE. Thus, this diagnosis has serious implications for the management of her present pregnancy, and for other aspects of her life ranging from contraception to thromboprophylaxis in future pregnancies and hormone replacement therapy in later life. It is therefore critical that all women with symptoms or signs that suggest venous thromboembolism have appropriate investigation and diagnosis based on objective diagnostic tests.
The current diagnostic approach in suspected PE is based on sequential diagnostic tests: 1) assessment of clinical probability, 2) fibrin D-dimer measurement, 3) compression ultrasonography of lower limb veins and 4) multi-slice computed tomography (MSCT). However, physicians are reluctant to perform MSCT in pregnant women because of potential adverse effect of radiation exposure to the fetus. For this reason, ventilation/perfusion or perfusion-only lung scan has been the cornerstone of PE diagnosis in pregnant women. Indeed, perfusion lung scan was assumed to be associated with less radiation than computed tomography (CT). However, this technique is now widely abandoned in the usual diagnostic strategy of PE for the following reasons: it is not widely available; its interpretation may be difficult and the test may be inconclusive in the presence of other chest abnormalities. Moreover, recent data convincingly show that the radiation exposure associated with single-slice or multi-slice CT exposes the fetus to less radiation than perfusion lung scan.
Read more
However, the use of CT has never been adequately validated in pregnant women with clinically suspected PE. The investigators, therefore, plan to set up a prospective management study in which pregnant women with suspected PE will undergo a sequential diagnostic strategy based on 1) assessment of clinical probability 2) D-dimer measurement 3) compression ultrasonography, and 4) MSCT.
Nowadays, the overestimated fear of radiation exposure for the fetus leads to an irrational attitude and inadequate investigations in pregnant women with suspected PE, even though both European [3, 4] and North-American guidelines [5] suggest that only objective testing may accurately rule out the disease. The proposed study should lead to an increased awareness of the risks and benefits of appropriate imaging in pregnant women suspected of PE and should result in a more rational management of this under-studied patient group.
Read the detailed description
Venous thromboembolism (VTE) remains a major cause of maternal morbidity and mortality in developed countries. Objective diagnosis of pulmonary embolism (PE) and/or deep vein thrombosis (DVT) in pregnancy is crucial. Failure to identify PE or/or DVT will place the mother's life at risk, and unnecessary treatment will not only expose her to anticoagulants but will also label her as having had VTE. Thus, this diagnosis has serious implications for the management of her present pregnancy, and for other aspects of her life ranging from contraception to thromboprophylaxis in future pregnancies and hormone replacement therapy in later life. It is therefore critical that all women with symptoms or signs that suggest venous thromboembolism have appropriate investigation and diagnosis based on objective diagnostic tests.
Diagnosis of VTE on a clinical basis is unreliable, especially during pregnancy because leg swelling and mild dyspnea are frequent during normal pregnancy.
The current diagnostic approach in suspected PE is based on sequential diagnostic tests: 1) assessment of clinical probability, 2) fibrin D-dimer measurement, 3) compression ultrasonography of lower limb veins and 4) multi-slice computed tomography (MSCT). However, physicians are reluctant to perform MSCT in pregnant women because of potential adverse effect of radiation exposure to the fetus. For this reason, ventilation/perfusion or perfusion-only lung scan has been the cornerstone of PE diagnosis in pregnant women. Indeed, perfusion lung scan was assumed to be associated with less radiation than computed tomography (CT). However, this technique is now widely abandoned in the usual diagnostic strategy of PE for the following reasons: it is not widely available; its interpretation may be difficult and the test may be inconclusive in the presence of other chest abnormalities. Moreover, recent data convincingly show that the radiation exposure associated with single-slice or multi-slice CT exposes the fetus to less radiation than perfusion lung scan.
However, the use of CT has never been adequately validated in pregnant women with clinically suspected PE. We, therefore, plan to set up a prospective management study in which pregnant women with suspected PE will undergo a sequential diagnostic strategy based on 1) assessment of clinical probability 2) D-dimer measurement 3) compression ultrasonography, and 4) MSCT.
Nowadays, the overestimated fear of radiation exposure for the fetus leads to an irrational attitude and inadequate investigations in pregnant women with suspected PE, even though both European and North-American guidelines suggest that only objective testing may accurately rule out the disease. The proposed study should lead to an increased awareness of the risks and benefits of appropriate imaging in pregnant women suspected of PE and should result in a more rational management of this under-studied patient group.
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Being tested
- Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT.
- Keywords
- Pregnancy, Pulmonary embolism, MSCT
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT.Other
| Study group | Role | What they receive |
|---|---|---|
| Ct scan | Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer measurement, lower limb compression ultrasonography and multi-slice computed tomography. Receives: Other: Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a symptomatic thromboembolic event in the three month follow-up among those in whom PE was ruled out by the diagnostic strategy and who were left untreated by anticoagulants.
Measured: 3 months
Secondary outcomes (3)
Efficacy of non invasive testing
Measured: 3 months
Proportion of patients with a negative D-dimer result
Measured: 3 months
Proportion of patients with a lower limb venous ultrasound showing a proximal DVT
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2017
- Study completionAug 2017
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 University Hospital, GenevaThe 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
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University Hospital, Brest
- Responsible party
- Principal investigator, Marc Righini, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771303
- Sponsor's protocol ID
- 3200B0-120760
- Other IDs
- Swiss medical Foundation
- Status last verified
- May 2018
- First submitted
- 10 Oct 2008
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
- ClinicalTrials.gov ID
- NCT00771303
- Acronym / sponsor ID
- 3200B0-120760
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Keywords
- Pregnancy, Pulmonary embolism, MSCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University Hospital, Brest
- Study start
- Sep 2008 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Oct 2008 (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.
Venous thromboembolism (VTE) remains a major cause of maternal morbidity and mortality in developed countries. Objective diagnosis of pulmonary embolism (PE) and/or deep vein thrombosis (DVT) in pregnancy is crucial. Failure to identify PE or/or DVT will place the mother's life at risk, and unnecessary treatment will not only expose her to anticoagulants but will also label her as having had VTE. Thus, this diagnosis has serious implications for the management of her present pregnancy, and for other aspects of her life ranging from contraception to thromboprophylaxis in future pregnancies and hormone replacement therapy in later life. It is therefore critical that all women with symptoms or signs that suggest venous thromboembolism have appropriate investigation and diagnosis based on objective diagnostic tests.
The current diagnostic approach in suspected PE is based on sequential diagnostic tests: 1) assessment of clinical probability, 2) fibrin D-dimer measurement, 3) compression ultrasonography of lower limb veins and 4) multi-slice computed tomography (MSCT). However, physicians are reluctant to perform MSCT in pregnant women because of potential adverse effect of radiation exposure to the fetus. For this reason, ventilation/perfusion or perfusion-only lung scan has been the cornerstone of PE diagnosis in pregnant women. Indeed, perfusion lung scan was assumed to be associated with less radiation than computed tomography (CT). However, this technique is now widely abandoned in the usual diagnostic strategy of PE for the following reasons: it is not widely available; its interpretation may be difficult and the test may be inconclusive in the presence of other chest abnormalities. Moreover, recent data convincingly show that the radiation exposure associated with single-slice or multi-slice CT exposes the fetus to less radiation than perfusion lung scan.
However, the use of CT has never been adequately validated in pregnant women with clinically suspected PE. The investigators, therefore, plan to set up a prospective management study in which pregnant women with suspected PE will undergo a sequential diagnostic strategy based on 1) assessment of clinical probability 2) D-dimer measurement 3) compression ultrasonography, and 4) MSCT.
Nowadays, the overestimated fear of radiation exposure for the fetus leads to an irrational attitude and inadequate investigations in pregnant women with suspected PE, even though both European [3, 4] and North-American guidelines [5] suggest that only objective testing may accurately rule out the disease. The proposed study should lead to an increased awareness of the risks and benefits of appropriate imaging in pregnant women suspected of PE and should result in a more rational management of this under-studied patient group.
Detailed description
Venous thromboembolism (VTE) remains a major cause of maternal morbidity and mortality in developed countries. Objective diagnosis of pulmonary embolism (PE) and/or deep vein thrombosis (DVT) in pregnancy is crucial. Failure to identify PE or/or DVT will place the mother's life at risk, and unnecessary treatment will not only expose her to anticoagulants but will also label her as having had VTE. Thus, this diagnosis has serious implications for the management of her present pregnancy, and for other aspects of her life ranging from contraception to thromboprophylaxis in future pregnancies and hormone replacement therapy in later life. It is therefore critical that all women with symptoms or signs that suggest venous thromboembolism have appropriate investigation and diagnosis based on objective diagnostic tests.
Diagnosis of VTE on a clinical basis is unreliable, especially during pregnancy because leg swelling and mild dyspnea are frequent during normal pregnancy.
The current diagnostic approach in suspected PE is based on sequential diagnostic tests: 1) assessment of clinical probability, 2) fibrin D-dimer measurement, 3) compression ultrasonography of lower limb veins and 4) multi-slice computed tomography (MSCT). However, physicians are reluctant to perform MSCT in pregnant women because of potential adverse effect of radiation exposure to the fetus. For this reason, ventilation/perfusion or perfusion-only lung scan has been the cornerstone of PE diagnosis in pregnant women. Indeed, perfusion lung scan was assumed to be associated with less radiation than computed tomography (CT). However, this technique is now widely abandoned in the usual diagnostic strategy of PE for the following reasons: it is not widely available; its interpretation may be difficult and the test may be inconclusive in the presence of other chest abnormalities. Moreover, recent data convincingly show that the radiation exposure associated with single-slice or multi-slice CT exposes the fetus to less radiation than perfusion lung scan.
However, the use of CT has never been adequately validated in pregnant women with clinically suspected PE. We, therefore, plan to set up a prospective management study in which pregnant women with suspected PE will undergo a sequential diagnostic strategy based on 1) assessment of clinical probability 2) D-dimer measurement 3) compression ultrasonography, and 4) MSCT.
Nowadays, the overestimated fear of radiation exposure for the fetus leads to an irrational attitude and inadequate investigations in pregnant women with suspected PE, even though both European and North-American guidelines suggest that only objective testing may accurately rule out the disease. The proposed study should lead to an increased awareness of the risks and benefits of appropriate imaging in pregnant women suspected of PE and should result in a more rational management of this under-studied patient group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ct scan | – | Other: Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT.Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer measurement, lower limb compression ultrasonography and multi-slice computed tomography. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with suspected PE.
Key inclusion criteria (1 listed)
- All pregnant patients with a clinical suspicion of acute PE will be included in the study, provided they correspond to the following diagnostic and exclusion criteria, and they have signed an informed consent form.
Key exclusion criteria (5 listed)
- Age less than 18 years
- Absence of informed consent
- Patients allergic to contrast medium
- Impaired renal function (creatine clearance less than 30 ml/min as estimated by the Cockroft formula)
- Geographic inaccessibility for follow-up
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 |
|---|---|---|
| Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT. | Other | Ct scan |
Primary outcome
Proportion of patients with a symptomatic thromboembolic event in the three month follow-up among those in whom PE was ruled out by the diagnostic strategy and who were left untreated by anticoagulants.
Time frame: 3 months
3 secondary outcomes
Efficacy of non invasive testing
Time frame: 3 months
Proportion of patients with a negative D-dimer result
Time frame: 3 months
Proportion of patients with a lower limb venous ultrasound showing a proximal DVT
Time frame: 3 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 9 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Deep Vein Thrombosis, run by University Hospital, Geneva at 9 sites in 2 countries.
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 1 inclusion and 5 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Proportion of patients with a symptomatic thromboembolic event in the three month follow-up among those in whom PE was ruled out by the diagnostic strategy and who were left untreated by anticoagulants. (time frame: 3 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 9 May 2018.