Placental Vascular PathologiesAngioPredNCT00695942
Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease
An observational study of Placental Vascular Pathologies and Venous Thromboembolism Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world. Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to VTE by biological thrombophilia and are the principal cause of perinatal mortality. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Placental Vascular Pathologies, Venous Thromboembolism Diseases
- How many people
- 200 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2008to May 2012
- Phase
- Observational
- 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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: community sample
Who may be able to join
- previous history of one or more PVC episodes (preeclampsia, HELLPs, retroplacental hematoma, vascular IUGR<10th percentile, recurrence miscarriage >2, unexplained IUFD or IUFD after abruption placentae, eclampsia.
- Previous history of personal VTE
- Diabete (treated with diet or insulin)
- chronic hypertension
- chronic renal pathology
- lupus
Show all 11Show fewer
- obesity
- Antihopholipids syndrome
- early and late pregnancy (<18 years, >38 years)
- family history of cardiovascular disease of VTE
- known biological thrombophilia without any personal past history of PVC or VTE
Who cannot join
- Multiple pregnancy
- past history of in utero fetal death due to congenital malformations, rhesus incompatibility or an infection
- previous history of IUGR which etiology was a chromosomal, genic or infectious anomaly
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service d'Hématologie - CHU de Nîmes
Nîmes, 30000
Service de gynécologie Obstétrique
Nîmes, 30000
Service de Gynécologie Obstétrique - CHU Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler
Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world. Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to VTE by biological thrombophilia and are the principal cause of perinatal mortality. the identification of predictive factors of risk of occurrence or recurrence of two pathologies could enable us to propose an appropriate monitoring of patients at risk.
Read the detailed description
Main aim: To evaluate echographic, doppler and biological markers in a prospective manner as a potential predictive factor of risk of PVP and VTE.
- Keywords
- preeclampsia, eclampsia, retroplacental hematoma, vascular IUGR, IUFD, VTE
- Medical subject headings
- Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | pregnancy women |
What is being measured
The primary outcome is the main question the study is designed to answer.
sFlt1/plGF ratio
Measured: 20, 24, 28, 32, 36 weeks
Secondary outcomes (4)
SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE
Measured: 20, 24, 28, 32, 36 SA
thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE
Measured: 20, 24, 28, 32 and 36 weeks
sEng, rTFPI, D-Dimer, uCRP, PP13 as potential predictive factor of risk of PVP and or VTE
Measured: 20, 24, 28, 32 and 36 weeks
echographic data as potential predictive factors of VTE and or PVP
Measured: 22 and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placental Vascular PathologiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ARGOS, Association de la Vallée de l'Ondaine
- Responsible party
- Sponsor
- Investigators
- Céline CHAULEUR, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695942
- Sponsor's protocol ID
- 0708115
- Other IDs
- 2007-A01448-45, DGS 2008-0167
- Acronym
- AngioPred
- Status last verified
- May 2012
- First submitted
- 5 Jun 2008
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler
- ClinicalTrials.gov ID
- NCT00695942
- Acronym / sponsor ID
- AngioPred / 0708115
- Keywords
- preeclampsia, eclampsia, retroplacental hematoma, vascular IUGR, IUFD, VTE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- ARGOS, Association de la Vallée de l'Ondaine
- Study start
- Jun 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Jun 2008 (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.
Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world. Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to VTE by biological thrombophilia and are the principal cause of perinatal mortality. the identification of predictive factors of risk of occurrence or recurrence of two pathologies could enable us to propose an appropriate monitoring of patients at risk.
Detailed description
Main aim: To evaluate echographic, doppler and biological markers in a prospective manner as a potential predictive factor of risk of PVP and VTE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –pregnancy women |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- community sample
Key inclusion criteria (11 listed)
- previous history of one or more PVC episodes (preeclampsia, HELLPs, retroplacental hematoma, vascular IUGR<10th percentile, recurrence miscarriage >2, unexplained IUFD or IUFD after abruption placentae, eclampsia.
- Previous history of personal VTE
- Diabete (treated with diet or insulin)
- chronic hypertension
- chronic renal pathology
Key exclusion criteria (3 listed)
- Multiple pregnancy
- past history of in utero fetal death due to congenital malformations, rhesus incompatibility or an infection
- previous history of IUGR which etiology was a chromosomal, genic or infectious anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sFlt1/plGF ratio
Time frame: 20, 24, 28, 32, 36 weeks
4 secondary outcomes
SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE
Time frame: 20, 24, 28, 32, 36 SA
thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE
Time frame: 20, 24, 28, 32 and 36 weeks
sEng, rTFPI, D-Dimer, uCRP, PP13 as potential predictive factor of risk of PVP and or VTE
Time frame: 20, 24, 28, 32 and 36 weeks
echographic data as potential predictive factors of VTE and or PVP
Time frame: 22 and 32 weeks
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 17 May 2012.
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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.
Céline CHAULEUR, MD principal investigator
CHU de Saint-Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placental Vascular Pathologies and Venous Thromboembolism Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites 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 11 inclusion and 3 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 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
sFlt1/plGF ratio (time frame: 20, 24, 28, 32, 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2012.