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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. (PRECOPE)

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ClinicalTrials.gov Identifier: NCT03455387
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Metropole Savoie

Brief 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.

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.


Condition or disease Intervention/treatment
Pre-Eclampsia HELLP Syndrome Fetal Death Eclampsia Placental Abruption Fetal Growth Retardation, Antenatal Diagnostic Test: sampling of the serum marker sFlt1 and PlGF

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.


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : March 10, 2020
Estimated Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
sampling of serum marker Flt1 and PIGF
sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery
Diagnostic Test: sampling of the serum marker sFlt1 and PlGF
sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery




Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples Without DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All pregnant women with a diagnosis of placental vascular disease during the third trimester
Criteria

Inclusion Criteria:

  • pregnant woman with a diagnosis of placental vascular disease (gestational hypertension, preeclampsia, IUGR)

Exclusion Criteria:

  • patient who refuses the obstetric follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455387


Contacts
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Contact: Emmanuel Decroisette +33456808205 emmanuel.decroisette@ch-metropole-savoie.fr
Contact: Fabienne Prieur +33479965999 fabienne.prieur@ch-metropole-savoie.fr

Locations
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France
CHMetropoleSavoie Recruiting
Chambéry, Savoie, France, 73000
Contact: Emmanuel Decroisette    +33456808205    emmanuel.decroisette@ch-metropole-savoie.fr   
Contact: Christophe Doche       christophe.doche@ch-metropole-savoie.fr   
CHU de Brest Recruiting
Brest, France, 29200
Contact: TREMOUILHAC Christophe       christophe.tremouilhac@chu-brest.fr   
Centre Hospitalier Alpes Léman Not yet recruiting
Contamine-sur-Arve, France, 74130
Contact: Anne DUCLUSAUD       aduclusaud@ch-alpes-leman.fr   
Groupe Hospitalier du Havre Recruiting
Le Havre, France, 76083
Contact: GROSSETTI Elizabeth       elizabeth.grossetti@ch-havre.fr   
CHU de Limoges Recruiting
Limoges, France, 87042
Contact: COSTE-MAZEAU Perrine       PERRINE.COSTEMAZEAU@chu-limoges.fr   
Centre Hospitalier Annecy Genevois Recruiting
Metz-Tessy, France, 74370
Contact: Bénédicte Breton       bbreton@ch-annecygenevois.fr   
Hôpitaux du Léman Recruiting
Thonon-les-Bains, France, 74200
Contact: Nicolas AGAR       n-agar@ch-hopitauxduleman.fr   
Sponsors and Collaborators
Centre Hospitalier Metropole Savoie
Investigators
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Study Director: Christophe DOCHE Centre Hospitalier Metropole Savoie

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Responsible Party: Centre Hospitalier Metropole Savoie
ClinicalTrials.gov Identifier: NCT03455387     History of Changes
Other Study ID Numbers: CHMS16001
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Metropole Savoie:
sFLt1
PlGF
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Fetal Growth Retardation
Fetal Death
HELLP Syndrome
Abruptio Placentae
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Death
Obstetric Labor Complications
Placenta Diseases