Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University Hospital, Geneva
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00771303
First received: October 10, 2008
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
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.
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of non invasive testing [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Proportion of patients with a negative D-dimer result [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Proportion of patients with a lower limb venous ultrasound showing a proximal DVT [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Nt-pro BNP measurement


Estimated Enrollment: 300
Study Start Date: September 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Pregnant patients with suspected PE will undergo a strategy based on clinical probability assessment, D-dimer, lower limb vein ultrasonography and MSCT.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women with suspected PE.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771303

Locations
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   
Sponsors and Collaborators
University Hospital, Geneva
Swiss National Science Foundation
  More Information

No publications provided

Responsible Party: Marc Righini, Geneva University Hospital
ClinicalTrials.gov Identifier: NCT00771303     History of Changes
Other Study ID Numbers: 3200B0-120760, Swiss medical Foundation
Study First Received: October 10, 2008
Last Updated: October 12, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Pregnancy
Pulmonary embolism
MSCT

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014