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.

Completed

• Conditions: Eclampsia; HELLP Syndrome; Fetal Growth Retardation, Antenatal; Pre-Eclampsia; Fetal Death; Placental Abruption
• Interventions: Diagnostic Test: sampling of the serum marker sFlt1 and PlGF

• Registration Number: NCT03455387
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-01-10
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-06
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 233

Inclusion Criteria

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

Exclusion Criteria

• patient who refuses the obstetric follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sampling of serum marker Flt1 and PIGF	sampling of the serum marker sFlt1 and PlGF	sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery

Primary Outcome Measures

Name	Time	Method
Arisen of a maternal and/or fetal severe complication	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.

Trial Locations

Locations (7)

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