Clinical trial NCT03455387: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
HELLP Syndrome
Fetal Death
Eclampsia
Placental Abruption
Fetal Growth Retardation, Antenatal
Keywords: sFLt1
PlGF
Lead sponsor: Centre Hospitalier Metropole Savoie
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 233
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women with a diagnosis of placental vascular disease during the third trimester

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.

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

Primary outcomes:
measure: Arisen of a maternal and/or fetal severe complication
timeFrame: during the pregnancy from 24 weeks of gestation until delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Chambéry
country: France
facility: CHMetropoleSavoie
state: Savoie
city: Brest
country: France
facility: CHU de Brest
city: Contamine-sur-Arve
country: France
facility: Centre Hospitalier Alpes Léman
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
city: Limoges
country: France
facility: CHU de Limoges
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Thonon-les-Bains
country: France
facility: Hôpitaux du Léman
Study officials:
affiliation: Centre Hospitalier Metropole Savoie
name: Christophe DOCHE
role: STUDY_DIRECTOR
References: