Pulmonary ThromboembolismCTVENPOSTPARTNCT02616991
Computed Tomography CT Venography During Postpartum Venous Thromboembolism
A study testing computed tomography venography in people with Pulmonary Thromboembolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pulmonary Thromboembolism
- What is being tested?
- computed tomography venography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2016to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Thromboembolism
- Being tested
- computed tomography venography
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomography venographyProcedure or surgery
systematically performing computed tomography venography in addition to thoracic computed tomography angiography
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | computed tomography venography Receives: Procedure: computed tomography venography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of detected venous thromboembolism (VTE) based on Computed Tomography Angiography (CTA) plus Computed Tomography Venography (CTV)
VTE detection rate for readings based on CTA plus CTV as compared to readings based on CTA alone
Measured: one day
Secondary outcomes (2)
Radiation doses due to CT venography
Measured: 3 months
kappa coefficients assessing inter-readers agreement for CT venography readings
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study start4 Jun 2016
- Primary completion4 Dec 2020
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ThromboembolismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre REVEL, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisGuy MEYER, PhD, Study chair, University of Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616991
- Sponsor's protocol ID
- 2015-002741-64
- Other IDs
- 2015-A01262-47, 2015
- Acronym
- CTVENPOSTPART
- Status last verified
- Sep 2025
- First submitted
- 25 Nov 2015
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Revel MP, Sanchez O, Dechoux S, Couchon S, Frija G, Cazejust J, Chatellier G, Meyer G. Contribution of indirect computed tomographic venography to the diagnosis of postpartum venous thromboembolism. J Thromb Haemost. 2008 Sep;6(9):1478-81. doi: 10.1111/j.1538-7836.2008.03078.x. Epub 2008 Jul 8.
PubMed 18627442Revel MP, Chassagnon G, Sanchez O, Ferretti G, Millet I, Rocher L, Maitre S, Lederlin M, Ducou-le-Pointe H, Rousset P, Bennani S, Zins M, Bruneau B, Tissot V, Alison M, Canniff E, Siauve N, Vandeventer S, Le Blanche AF, Planquette B, Tsatsaris V, Coste J. CT venography for the diagnosis of postpartum venous thromboembolism: a prospective multi-center cohort study. Eur Radiol. 2024 Nov;34(11):7419-7428. doi: 10.1007/s00330-024-10791-8. Epub 2024 May 23.
PubMed 38782788
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of CT Venography for Diagnosing Venous Thromboembolism During Postpartum
- ClinicalTrials.gov ID
- NCT02616991
- Acronym / sponsor ID
- CTVENPOSTPART / 2015-002741-64
- Conditions
- Pulmonary Thromboembolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 4 Jun 2016 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Procedure: computed tomography venographycomputed tomography venography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomography venographysystematically performing computed tomography venography in addition to thoracic computed tomography angiography | Procedure or surgery | Cohort |
Primary outcome
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
2 secondary outcomes
Radiation doses due to CT venography
Time frame: 3 months
kappa coefficients assessing inter-readers agreement for CT venography readings
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 18627442Revel MP, Sanchez O, Dechoux S, Couchon S, Frija G, Cazejust J, Chatellier G, Meyer G. Contribution of indirect computed tomographic venography to the diagnosis of postpartum venous thromboembolism. J Thromb Haemost. 2008 Sep;6(9):1478-81. doi: 10.1111/j.1538-7836.2008.03078.x. Epub 2008 Jul 8.
- Results publication: PubMed 38782788Revel MP, Chassagnon G, Sanchez O, Ferretti G, Millet I, Rocher L, Maitre S, Lederlin M, Ducou-le-Pointe H, Rousset P, Bennani S, Zins M, Bruneau B, Tissot V, Alison M, Canniff E, Siauve N, Vandeventer S, Le Blanche AF, Planquette B, Tsatsaris V, Coste J. CT venography for the diagnosis of postpartum venous thromboembolism: a prospective multi-center cohort study. Eur Radiol. 2024 Nov;34(11):7419-7428. doi: 10.1007/s00330-024-10791-8. Epub 2024 May 23.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Thromboembolism
Active, not recruitingObservational study
Epidemiology of Venous Thrombosis and Pulmonary Embolism
Cardiovascular Diseases, Pulmonary Embolism
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Pierre REVEL, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Guy MEYER, PhD study chair
University of Paris 5 - Rene Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography venography in people with Pulmonary Thromboembolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of detected venous thromboembolism (VTE) based on Computed Tomography Angiography (CTA) plus Computed Tomography Venography (CTV) (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616991, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.