Placental Vascular PathologiesSTRATHEGENCT00745212
Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women
An observational study of Placental Vascular Pathologies and Venous Thromboembolism Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The venous thromboembolism is one of the first causes of maternal mortality. Until 2003, only a few recommendations were available on the optimal use of antithrombotic therapy as a preventive measure against thromboembolism in pregnant women. In this study, we propose : 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placental Vascular Pathologies, Venous Thromboembolism Diseases
- How many people
- 2,280 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Jun 2013
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- multiparous or primiparous parturients followed in one of the participating centers
- Presenting at least one risk factor of venous thromboembolic pathology and/or placental vascular pathology
Who cannot join
- parturient that can't be followed
- unknown familial or personal previous history
- Parturient with a contraindication to use of the treatment recommended by the therapeutic strategy
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie Obstétrique - CHU Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Prospective Multicentric Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women With a Risk of Thromboembolism and/or a Risk of Placental Vascular Complication, Strategy Determined With a Risk Score.
The venous thromboembolism is one of the first causes of maternal mortality. Until 2003, only a few recommendations were available on the optimal use of antithrombotic therapy as a preventive measure against thromboembolism in pregnant women. In this study, we propose :
- To gather the experts who took part in the French consensus conference and the local experts to create a score in accordance with the national and international consensus and to give some precise therapeutic strategies.
- To evaluate the discriminant, feasible and useful character of this new score by a prospective multicentric study including 2000 pregnant women with a risk of thromboembolism or placental vascular pathology who will benefit from therapeutic strategies defined by the new score. .
Read the detailed description
Purpose : To create a score inspired by our first experience i.e. simple, standardized and quickly usable in day-to-day practice to individualize antithrombotics prescription to women at risk.
- Keywords
- venous thromboembolism diseases, placental vascular pathologies, antithrombotic treatment, symptomatic thromboembolic events, pregnant women, score, therapeutic strategies, heparin, aspirin, pregnancy pathology
What is being measured
The primary outcome is the main question the study is designed to answer.
Occuring of symptomatic thromboembolic events and/or placental vascular pathology, any other pregnancy pathology requiring hospitalization, any complications from the antithrombotic treatment
Measured: first, second or third trimester during pregnancy or post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,280 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline CHAULEUR, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745212
- Sponsor's protocol ID
- 0508080
- Acronym
- STRATHEGE
- Status last verified
- Nov 2017
- First submitted
- 1 Sep 2008
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chauleur C, Gris JC, Laporte S, Rancon F, Varlet MN, Decousus H, Mismetti P; STRATHEGE Group. Use of the Delphi method to facilitate antithrombotics prescription during pregnancy. Thromb Res. 2010 Aug;126(2):88-92. doi: 10.1016/j.thromres.2010.01.012. Epub 2010 Feb 13.
PubMed 20153880
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women With a Risk of Thromboembolism and/or a Risk of Placental Vascular Complication, Strategy Determined With a Risk Score.
- ClinicalTrials.gov ID
- NCT00745212
- Acronym / sponsor ID
- STRATHEGE / 0508080
- Keywords
- venous thromboembolism diseases, placental vascular pathologies, antithrombotic treatment, symptomatic thromboembolic events, pregnant women, score, therapeutic strategies, heparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,280 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Sep 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.
The venous thromboembolism is one of the first causes of maternal mortality. Until 2003, only a few recommendations were available on the optimal use of antithrombotic therapy as a preventive measure against thromboembolism in pregnant women. In this study, we propose :
- To gather the experts who took part in the French consensus conference and the local experts to create a score in accordance with the national and international consensus and to give some precise therapeutic strategies.
- To evaluate the discriminant, feasible and useful character of this new score by a prospective multicentric study including 2000 pregnant women with a risk of thromboembolism or placental vascular pathology who will benefit from therapeutic strategies defined by the new score. .
Detailed description
Purpose : To create a score inspired by our first experience i.e. simple, standardized and quickly usable in day-to-day practice to individualize antithrombotics prescription to women at risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (2 listed)
- multiparous or primiparous parturients followed in one of the participating centers
- Presenting at least one risk factor of venous thromboembolic pathology and/or placental vascular pathology
Key exclusion criteria (3 listed)
- parturient that can't be followed
- unknown familial or personal previous history
- Parturient with a contraindication to use of the treatment recommended by the therapeutic strategy
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
Occuring of symptomatic thromboembolic events and/or placental vascular pathology, any other pregnancy pathology requiring hospitalization, any complications from the antithrombotic treatment
Time frame: first, second or third trimester during pregnancy or post-partum
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 9 Nov 2017.
- Derived from this study: PubMed 20153880Chauleur C, Gris JC, Laporte S, Rancon F, Varlet MN, Decousus H, Mismetti P; STRATHEGE Group. Use of the Delphi method to facilitate antithrombotics prescription during pregnancy. Thromb Res. 2010 Aug;126(2):88-92. doi: 10.1016/j.thromres.2010.01.012. Epub 2010 Feb 13.
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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 PhD principal investigator
CHU de Saint-Etienne
1 site 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 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 2 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 9 Nov 2017. 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?
Occuring of symptomatic thromboembolic events and/or placental vascular pathology, any other pregnancy pathology requiring hospitalization, any complications from the antithrombotic treatment (time frame: first, second or third trimester during pregnancy or post-partum). 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 NCT00745212, which also lists 1 linked publication.
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 9 Nov 2017.