Pre-EclampsiaPRECOPENCT03455387
Evaluation of the Serum Markers sFLt1 and PlGF for the Prediction of the Complications of the Placental Vascular Pathologies in the 3rd Quarter of the Pregnancy.
An observational study of Pre-Eclampsia and HELLP Syndrome, run by Centre Hospitalier Metropole Savoie at 7 sites in France.
Trial summary
The pre-eclampsia is a frequent pathology, concerning approximately 5 % of the pregnancies.The pre-eclampsia can evolve into severe maternal and\or foetal complications and is a major cause of mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia, HELLP Syndrome, Fetal Death
- What is being tested?
- sampling of the serum marker sFlt1 and PlGF
- How many people
- 233 participants
- Where
- 7 sitesFrance
- Study dates
- 10 Jan 2017to 31 Dec 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All pregnant women with a diagnosis of placental vascular disease during the third trimester
Who may be able to join
- pregnant woman with a diagnosis of placental vascular disease (gestational hypertension, preeclampsia, IUGR)
Who cannot join
- patient who refuses the obstetric follow-up
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Brest
Brest, 29200
CHMetropoleSavoie
Chambéry, Savoie, 73000
Centre Hospitalier Alpes Léman
Contamine-sur-Arve, 74130
Groupe Hospitalier du Havre
Le Havre, 76083
CHU de Limoges
Limoges, 87042
Centre Hospitalier Annecy Genevois
Metz-Tessy, 74370
Hôpitaux du Léman
Thonon-les-Bains, 74200
About this study
The pre-eclampsia is a frequent pathology, concerning approximately 5 % of the pregnancies.The pre-eclampsia can evolve into severe maternal and\or foetal complications and is a major cause of mortality.
The purpose of the study will to estimate the relevance of the serum markers sFlt1 and PlGF to predict the arisen of severe complications at these patients, what would allow to decrease the materno-fœtale morbi-mortality due to the pathology.
Read the detailed description
The pre-eclampsia is a frequent pathology, concerning approximately 5 % of the pregnancies. It is a major cause of mortality, mainly in the developing country. His incidence tends to increase in the developed countries. In the absence of adapted coverage, the pre-eclampsia can evolve into severe maternal and\or foetal complications (eclampsia, foetal intra-uterine, dead HELLP syndrome, lung acute oedema, stunting in utero).
The pre-eclampsia is a part of placental vascular pathologies. Several studies showed that these pathologies are due to a defect of trophoblastic invasion, secondary in an imbalance in the balance of factors pro and antiangiogéniques (PlGF, sFlt1).
Studies also demonstrated that, for a patient presenting a placental vascular pathology, the rate of PlGF is decreased and conversely for the rate of sFlt1. Studies show that the duration of the pregnancy, of a patient presenting a placentary vascular pathology, is correlated at the rate of these markers.
There is at present no reliable predictive examination to estimate the arisen of severe complications for a patient presenting a placental vascular pathology. The purpose of the study will to estimate the relevance of the serum markers sFlt1 and PlGF to predict the arisen of severe complications for these patients.
- Conditions
- Pre-Eclampsia, HELLP Syndrome, Fetal Death, Eclampsia, Placental Abruption, Fetal Growth Retardation, Antenatal
- Being tested
- sampling of the serum marker sFlt1 and PlGF
- Keywords
- sFLt1, PlGF
- Medical subject headings
- Pre-Eclampsia, HELLP Syndrome, Fetal Death, Eclampsia, Abruptio Placentae, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sampling of the serum marker sFlt1 and PlGFDiagnostic test
sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery
| Study group | Role | What they receive |
|---|---|---|
| sampling of serum marker Flt1 and PIGF | sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery Receives: Diagnostic Test: sampling of the serum marker sFlt1 and PlGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arisen of a maternal and/or fetal severe complication
The severe maternal complication are : placental abruption, HELLP syndrome, Lung acute oedema ; eclampsia, maternal death.
The fetal severe complications are : intrauterine grow retardation, fetal demise.
Measured: during the pregnancy from 24 weeks of gestation until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start10 Jan 2017
- Primary completion20 Dec 2019
- Study completion31 Dec 2019
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe DOCHE, Study director, Centre Hospitalier Metropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455387
- Sponsor's protocol ID
- CHMS16001
- Acronym
- PRECOPE
- Status last verified
- Jun 2022
- First submitted
- 28 Feb 2018
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Serum Markers sFLt1 and PlGF for the Prediction of the Complications of the Placental Vascular Pathologies in the 3rd Quarter of the Pregnancy.
- ClinicalTrials.gov ID
- NCT03455387
- Acronym / sponsor ID
- PRECOPE / CHMS16001
- Conditions
- Pre-Eclampsia, HELLP Syndrome, Fetal Death, Eclampsia, Placental Abruption, Fetal Growth Retardation, Antenatal
- Keywords
- sFLt1, PlGF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Mar 2018 (actual)
- 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 pre-eclampsia is a frequent pathology, concerning approximately 5 % of the pregnancies.The pre-eclampsia can evolve into severe maternal and\or foetal complications and is a major cause of mortality.
The purpose of the study will to estimate the relevance of the serum markers sFlt1 and PlGF to predict the arisen of severe complications at these patients, what would allow to decrease the materno-fœtale morbi-mortality due to the pathology.
Detailed description
The pre-eclampsia is a frequent pathology, concerning approximately 5 % of the pregnancies. It is a major cause of mortality, mainly in the developing country. His incidence tends to increase in the developed countries. In the absence of adapted coverage, the pre-eclampsia can evolve into severe maternal and\or foetal complications (eclampsia, foetal intra-uterine, dead HELLP syndrome, lung acute oedema, stunting in utero).
The pre-eclampsia is a part of placental vascular pathologies. Several studies showed that these pathologies are due to a defect of trophoblastic invasion, secondary in an imbalance in the balance of factors pro and antiangiogéniques (PlGF, sFlt1).
Studies also demonstrated that, for a patient presenting a placental vascular pathology, the rate of PlGF is decreased and conversely for the rate of sFlt1. Studies show that the duration of the pregnancy, of a patient presenting a placentary vascular pathology, is correlated at the rate of these markers.
There is at present no reliable predictive examination to estimate the arisen of severe complications for a patient presenting a placental vascular pathology. The purpose of the study will to estimate the relevance of the serum markers sFlt1 and PlGF to predict the arisen of severe complications for these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sampling of serum marker Flt1 and PIGF | – | Diagnostic Test: sampling of the serum marker sFlt1 and PlGFsampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women with a diagnosis of placental vascular disease during the third trimester
Key inclusion criteria (1 listed)
- pregnant woman with a diagnosis of placental vascular disease (gestational hypertension, preeclampsia, IUGR)
Key exclusion criteria (1 listed)
- patient who refuses the obstetric follow-up
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 |
|---|---|---|
| sampling of the serum marker sFlt1 and PlGFsampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery | Diagnostic test | sampling of serum marker Flt1 and PIGF |
Primary outcome
Arisen of a maternal and/or fetal severe complication
Time frame: during the pregnancy from 24 weeks of gestation until delivery
The severe maternal complication are : placental abruption, HELLP syndrome, Lung acute oedema ; eclampsia, maternal death. The fetal severe complications are : intrauterine grow retardation, fetal demise.
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 14 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Christophe DOCHE study director
Centre Hospitalier Metropole Savoie
7 sites 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 and HELLP Syndrome, run by Centre Hospitalier Metropole Savoie at 7 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 1 inclusion and 1 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 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Arisen of a maternal and/or fetal severe complication (time frame: during the pregnancy from 24 weeks of gestation until delivery). 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 14 Jun 2022.