Computed Tomography CT Venography During Postpartum Venous Thromboembolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-04

Study Completion Date

2021-04-02

Brief Summary

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The purpose of this study is to determine whether systematically performing computed tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during the venous phase of opacification) in addition to thoracic CT angiography in women with suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism detection rate.

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Detailed Description

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Pulmonary embolism (PE) remains a leading cause of maternal death during postpartum in developed countries; Thoracic computed tomography angiography (CTA) is the first-line diagnostic test for PE suspicion, but has a 20 to 35% rate of inconclusiveness during pregnancy and postpartum, 2 to 3 times higher than that of the general population. CT venography (CTV) consists in a delayed CT acquisition of the abdomen, pelvis and lower limbs, 3 minutes after starting contrast administration. It can be used for detecting deep venous thrombosis (DVT), the source of emboli in most PEs. The investigators hypothesized most postpartum PEs are due to pelvic vein thrombosis and that detecting such pelvic DVT by performing systematic CTV could increase the overall venous thromboembolism (VTE) detection.

Conditions

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Pulmonary Thromboembolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cohort

computed tomography venography

Group Type EXPERIMENTAL

computed tomography venography

Intervention Type PROCEDURE

systematically performing computed tomography venography in addition to thoracic computed tomography angiography

Interventions

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computed tomography venography

systematically performing computed tomography venography in addition to thoracic computed tomography angiography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women with clinically suspected pulmonary embolism (PE) during the first 6 weeks postpartum, without any sign of severe PE (shock, hypotension), referred for CT angiography
* Absence of contraindication to iodinated contrast medium injection (Previous allergic reaction to iodinated contrast medium, renal insufficiency with creatine clearance less than 30mL/mn, uncontrolled hyperthyroidism)
* Age \> 18 years
* Health insurance
* Possibility to have 3-month follow-up
* Obtention of written informed consent (ability to give consent)

Exclusion Criteria

* Anticoagulation at therapeutic dosage for another reason than the suspicion of PE for more than 72 hours
* New pregnancy (In case of any doubt after medical history review, βHCG blood test must be realized to ensure patient's pregnancy status)
* Contrast medium extravasation during injection
* CTA or CTV not performed according to the study requirements

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No