Skip to main content
OpenTrials
Completed

NCT Number: NCT02616991

Computed Tomography CT Venography During Postpartum Venous Thromboembolism

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cochin Hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

computed tomography venography

Procedure

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

Primary outcomes

  1. Number of detected venous thromboembolism (VTE) based on Computed Tomography Angiography (CTA) plus Computed Tomography Venography (CTV)

    Time frame: one day

    VTE detection rate for readings based on CTA plus CTV as compared to readings based on CTA alone

Secondary outcomes

  1. Radiation doses due to CT venography

    Time frame: 3 months

  2. kappa coefficients assessing inter-readers agreement for CT venography readings

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Contribution of CT Venography for Diagnosing Venous Thromboembolism During Postpartum

Acronym: CTVENPOSTPART

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Nov 30, 2015
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.