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.

NCT ID: NCT03455387

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 233 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-10
• Study Completion Date: 2019-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

sampling of serum marker Flt1 and PIGF

sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery

sampling of the serum marker sFlt1 and PlGF

Intervention Type: DIAGNOSTIC_TEST

sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery

Interventions

sampling of the serum marker sFlt1 and PlGF

sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Metropole Savoie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe DOCHE

Role: STUDY_DIRECTOR

Centre Hospitalier Metropole Savoie

Locations

CHMetropoleSavoie

Chambéry, Savoie, France

CHU de Brest

Brest, , France

Centre Hospitalier Alpes Léman

Contamine-sur-Arve, , France

Groupe Hospitalier du Havre

Le Havre, , France

CHU de Limoges

Limoges, , France

Centre Hospitalier Annecy Genevois

Metz-Tessy, , France

Hôpitaux du Léman

Thonon-les-Bains, , France

Countries

France

Other Identifiers

CHMS16001

Identifier Type: -

Identifier Source: org_study_id