Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
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| ClinicalTrials.gov Identifier: NCT00771303 |
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Recruitment Status
: Unknown
Verified May 2015 by Marc Righini, University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted
: October 13, 2008
Last Update Posted
: May 28, 2015
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Pulmonary Embolism Deep Vein Thrombosis | Other: Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT. |
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 Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study |
| Study Start Date : | September 2008 |
| Estimated Primary Completion Date : | January 2016 |
| Estimated Study Completion Date : | April 2016 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT. |
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771303
| France | |
| Pierre-Marie ROY | Not yet recruiting |
| Angers, France, 49933 | |
| Contact: Pierre-Marie ROY, PU-PH | |
| Grégoire LE GAL | Recruiting |
| Brest, France, 29609 | |
| Contact: Grégoire LE GAL, PUPH 298347336 ext +33 gregoire.legal@chu-brest.fr | |
| Florence PARENT | Not yet recruiting |
| Clamart, France, 92141 | |
| Contact: Florence PARENT, PH | |
| Isabelle QUERE | Not yet recruiting |
| Montpellier, France, 34295 | |
| Contact: Isabelle QUERE, PU-PH | |
| Jean-Christophe GRIS | Not yet recruiting |
| Nîmes, France, 30029 | |
| Contact: Jean-Christophe GRIS, PU-PH | |
| Guy MEYER | Active, not recruiting |
| Paris, France, 75015 | |
| Caroline BOHEC | Not yet recruiting |
| Pau, France, 64000 | |
| Contact: Caroline BOHEC, PH | |
| Antoine ELIAS | Not yet recruiting |
| Toulon, France, 83056 | |
| Contact: Antoine ELAIS, PH | |
| Switzerland | |
| Marc Righini | Recruiting |
| Geneva, Switzerland, 1205 | |
| Contact: Marc Righini, MD marc.righini@hcuge.ch | |
| Responsible Party: | Marc Righini, Prof, University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT00771303 History of Changes |
| Other Study ID Numbers: |
3200B0-120760 Swiss medical Foundation |
| First Posted: | October 13, 2008 Key Record Dates |
| Last Update Posted: | May 28, 2015 |
| Last Verified: | May 2015 |
Keywords provided by Marc Righini, University Hospital, Geneva:
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Pregnancy Pulmonary embolism MSCT |
Additional relevant MeSH terms:
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Thrombosis Embolism Pulmonary Embolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Fibrin fragment D Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |