Computed Tomography CT Venography During Postpartum Venous Thromboembolism (CTVENPOSTPART)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Pulmonary Thromboembolism

Treatments

Procedure: computed tomography venography

Study type

Interventional

Funder types

Other

Identifiers

NCT02616991

2015-002741-64

2015-A01262-47 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

125 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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