Computed Tomography CT Venography During Postpartum Venous Thromboembolism (CTVENPOSTPART)

September 1, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Contribution of CT Venography for Diagnosing Venous Thromboembolism During Postpartum

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Paris
      • Paris, Paris, France, 75014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort
computed tomography venography
Procedure: computed tomography venography
systematically performing computed tomography venography in addition to thoracic computed tomography angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one day

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiation doses due to CT venography
Time Frame: 3 months
3 months
kappa coefficients assessing inter-readers agreement for CT venography readings
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Unité de Recherche Clinique Necker Cochin, France

Investigators

  • Principal Investigator: Marie-Pierre REVEL, MD, PhD, Assistance Publique - Hopitaux de Paris
  • Study Chair: Guy MEYER, PhD, University of Paris 5 - Rene Descartes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2016

Primary Completion (Actual)

December 4, 2020

Study Completion (Actual)

April 2, 2021

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimated)

November 30, 2015

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-002741-64
  • 2015-A01262-47 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Thromboembolism

Clinical Trials on computed tomography venography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe