Computed Tomography CT Venography During Postpartum Venous Thromboembolism

Not Applicable

Completed

• Conditions: Pulmonary Thromboembolism
• Interventions: Procedure: computed tomography venography

• Registration Number: NCT02616991
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-11-30
• Study Start: 2016-06-04
• Primary Completion: 2020-12-04
• Status Verified: 2021-04
• Study Completion: 2021-04-02
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	computed tomography venography	computed tomography venography

Primary Outcome Measures

Name	Time	Method
Number of detected venous thromboembolism (VTE) based on Computed Tomography Angiography (CTA) plus Computed Tomography Venography (CTV)	one day	VTE detection rate for readings based on CTA plus CTV as compared to readings based on CTA alone

Secondary Outcome Measures

Name	Time	Method
kappa coefficients assessing inter-readers agreement for CT venography readings	3 months
Radiation doses due to CT venography	3 months

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France