Pre EclampsiaPRESTIGENCT01261351
Study of Coagulation Activation Markers and Pre Eclampsia
An observational study of Pre Eclampsia, run by University Hospital, Lille at 1 site in France.
Trial summary
The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pre Eclampsia
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Jun 2014
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women from two University hospitals in France
Who may be able to join
- 18 years old
- diagnosis of pre eclampsia
Who cannot join
- multiple pregnancy
- less than 18 year old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications
The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.
Read the detailed description
100 pre-eclamptic patients will be compared to 200 control patients (100 control matched on gestational age at inclusion and 100 control matched on delivery mode (section).
Blood and urine samples will be collected at PE diagnosis, delivery and post partum.
Two axes will be considered:
- Thrombography, or kinetic measurement of thrombin generation, by studying the coagulant profile according to Hemker's method in CAT System (Calibrated Automated Thrombogram) and by thromboelastogram in ROTEM technique (delocalized coagulation analyzer), in parallel to specific activation markers (thrombin-antithrombin complex, fibrin monomers).
- The balance of prostacyclin/thromboxane A2 by using ELISA method for urine samples and genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase's promoter CYP8A1).
- Conditions
- Pre Eclampsia
- Keywords
- Pre eclampsia, Endogenous thrombin potential
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous thrombin potential
comparison of Endogenous thrombin potential between patients with Preclampsia (PE) (at the moment of the diagnosis of PE) compared to control (at the same gestational age)
Measured: at preeclampsia diagnosis
Secondary outcomes (3)
genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1
Measured: at pre eclampsia diagnosis
In preeclampsia group : correlation between biological markers and severity of the disease
correlation of endogenous thrombin potential and rotem results with : presence or absence of severe preeclampsia presence or absence of HELLP Syndrome presence or absence of IUGR presence or absence of eclampsia
Measured: at the diagnosis of preeclampsia
evolution of endogenous thrombin potential in women with preeclampsia
Study of the evolution of endogenous thrombin potential during the time period of diagnosis of preeclampsia to day 2 of the post partum.
Measured: between the diagnosis of preeclampsia and day 2 of the post partum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre EclampsiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Houfflin Debarge, PHD, Principal investigator, Universituy Hospital Of Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261351
- Sponsor's protocol ID
- 2008_16/0921
- Other IDs
- PHRC 2009/1910, 2009-A00526-51
- Acronym
- PRESTIGE
- Status last verified
- Dec 2014
- First submitted
- 26 Oct 2010
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications
- ClinicalTrials.gov ID
- NCT01261351
- Acronym / sponsor ID
- PRESTIGE / 2008_16/0921
- Conditions
- Pre Eclampsia
- Keywords
- Pre eclampsia, Endogenous thrombin potential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Dec 2010 (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 primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.
Detailed description
100 pre-eclamptic patients will be compared to 200 control patients (100 control matched on gestational age at inclusion and 100 control matched on delivery mode (section).
Blood and urine samples will be collected at PE diagnosis, delivery and post partum.
Two axes will be considered:
- Thrombography, or kinetic measurement of thrombin generation, by studying the coagulant profile according to Hemker's method in CAT System (Calibrated Automated Thrombogram) and by thromboelastogram in ROTEM technique (delocalized coagulation analyzer), in parallel to specific activation markers (thrombin-antithrombin complex, fibrin monomers).
- The balance of prostacyclin/thromboxane A2 by using ELISA method for urine samples and genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase's promoter CYP8A1).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women from two University hospitals in France
Key inclusion criteria (2 listed)
- 18 years old
- diagnosis of pre eclampsia
Key exclusion criteria (2 listed)
- multiple pregnancy
- less than 18 year old
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
Endogenous thrombin potential
Time frame: at preeclampsia diagnosis
comparison of Endogenous thrombin potential between patients with Preclampsia (PE) (at the moment of the diagnosis of PE) compared to control (at the same gestational age)
3 secondary outcomes
genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1
Time frame: at pre eclampsia diagnosis
In preeclampsia group : correlation between biological markers and severity of the disease
Time frame: at the diagnosis of preeclampsia
evolution of endogenous thrombin potential in women with preeclampsia
Time frame: between the diagnosis of preeclampsia and day 2 of the post partum period
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 18 Dec 2014.
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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.
Véronique Houfflin Debarge, PHD principal investigator
Universituy Hospital Of Lille, France
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 Pre Eclampsia, run by University Hospital, Lille 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 2 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 18 Dec 2014. 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?
Endogenous thrombin potential (time frame: at preeclampsia diagnosis). 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 18 Dec 2014.