Pre-EclampsiaNCT00485784
Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications
A study testing Blood test in people with Pre-Eclampsia, run by Assistance Publique Hopitaux De Marseille at 4 sites in France.
Trial summary
This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Blood test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 4 sitesFrance
- Study dates
- Jul 2007to Jul 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant patients aged more than 18 years and more than 12 weeks of gestation for FD group, 20 weeks of gestation for PE or IUGR group , presenting either:
- PE (arterial pressure more than 140 mm Hg and 90 mm Hg) and at least a proteinuria evaluated on stick (one point) or 300 mg/24h.
- IUGR with biometries below 5° percentile according to the graphs of fetal echography college after 20 weeks of gestation.
- FD after 12 weeks of gestation or with a cranio-caudal length of more than 45 mm.
- Normal pregnancy adjusted for gestational age and parity : Patient should have no cardio-vascular past with a normal complication at the inclusion time and from which pregnancy remains uneventful until the term. The onset of premature delivery, hypertension or fetal growth restriction will exclude patients from the control group.
- social security cover
- written informed consent
Who cannot join
- Foetal malformation
- APLS known
- Set back of patient consent
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique
Marseille, 13008
Hôpital Nord
Marseille, 13015
Hôpital de la Conception
Marseille, 13385
Chu Nice Hopital de L'Archet
Nice
About this study
This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC).
The objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.
Read more
We want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia.
Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after the birth.
Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.
Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate.
The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event.
The study will last 3 years. The number of patient to include is 280.
- Conditions
- Pre-Eclampsia
- Being tested
- Blood test
- Keywords
- Identify in a population of patients with a PE, an IUGR and a FD a modification of circulating endothelial biomarkers compared with normal pregnancy.
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Blood test
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | control group Receives: Other: Blood test |
| prééclampsies group | Experimental | prééclampsies group Receives: Other: Blood test |
| RCIU group | Experimental | RCIU group Receives: Other: Blood test |
| MFIU group | Experimental | MFIU group Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bring to light except the pregnancy within a population of presenting patients one EP, a RCIU and a MFIU a modification of biomarkers circulating endothéliaux with regard to the normal pregnancy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2012
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.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence BRETELLE, PU-PH, Principal investigator, Unité Mère-Enfant Hôpital Nord 13005 Marseille - Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485784
- Sponsor's protocol ID
- 2006/26
- Status last verified
- Aug 2014
- First submitted
- 12 Jun 2007
- Last updated
- 28 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications
- ClinicalTrials.gov ID
- NCT00485784
- Acronym / sponsor ID
- 2006/26
- Conditions
- Pre-Eclampsia
- Keywords
- Identify in a population of patients with a PE, an IUGR and a FD a modification of circulating endothelial biomarkers compared with normal pregnancy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2012 (actual)
- First posted
- 13 Jun 2007 (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.
This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC).
The objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.
We want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia.
Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after the birth.
Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.
Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate.
The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event.
The study will last 3 years. The number of patient to include is 280.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Other: Blood testcontrol group |
| prééclampsies group | Experimental | Other: Blood testprééclampsies group |
| RCIU group | Experimental | Other: Blood testRCIU group |
| MFIU group | Experimental | Other: Blood testMFIU group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- pregnant patients aged more than 18 years and more than 12 weeks of gestation for FD group, 20 weeks of gestation for PE or IUGR group , presenting either:
- PE (arterial pressure more than 140 mm Hg and 90 mm Hg) and at least a proteinuria evaluated on stick (one point) or 300 mg/24h.
- IUGR with biometries below 5° percentile according to the graphs of fetal echography college after 20 weeks of gestation.
- FD after 12 weeks of gestation or with a cranio-caudal length of more than 45 mm.
- Normal pregnancy adjusted for gestational age and parity : Patient should have no cardio-vascular past with a normal complication at the inclusion time and from which pregnancy remains uneventful until the term. The onset of premature delivery, hypertension or fetal growth restriction will exclude patients from the control group.
Key exclusion criteria (3 listed)
- Foetal malformation
- APLS known
- Set back of patient consent
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 |
|---|---|---|
| Blood testBlood test | Other | MFIU group, RCIU group, control group, prééclampsies group |
Primary outcome
Bring to light except the pregnancy within a population of presenting patients one EP, a RCIU and a MFIU a modification of biomarkers circulating endothéliaux with regard to the normal pregnancy.
Time frame: 3 years
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 28 Aug 2014.
Related trials for Pre-Eclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
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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.
Florence BRETELLE, PU-PH principal investigator
Unité Mère-Enfant Hôpital Nord 13005 Marseille - Assistance Publique Hôpitaux de Marseille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Pre-Eclampsia, run by Assistance Publique Hopitaux De Marseille at 4 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 7 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 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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?
Bring to light except the pregnancy within a population of presenting patients one EP, a RCIU and a MFIU a modification of biomarkers circulating endothéliaux with regard to the normal pregnancy. (time frame: 3 years). 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 28 Aug 2014.