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.

NCT03455387 | Completed

• 1 other identifier: CHMS16001
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 7

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.

Conditions

Pre-Eclampsia; HELLP Syndrome; Fetal Death; Eclampsia; Placental Abruption; Fetal Growth Retardation, Antenatal

Keywords

sFLt1; PlGF

Outcome Measures

Primary Outcomes (1)

• 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.

  during the pregnancy from 24 weeks of gestation until delivery

Study Arms (1)

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

Interventions

sampling of the serum marker sFlt1 and PlGF DIAGNOSTIC_TEST

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

sampling of serum marker Flt1 and PIGF

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women with a diagnosis of placental vascular disease during the third trimester

You may qualify if:

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

You may not qualify if:

• patient who refuses the obstetric follow-up

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (7)

CHMetropoleSavoie

Chambéry, Savoie, 73000, France

Location

CHU de Brest

Brest, 29200, France

Location

Centre Hospitalier Alpes Léman

Contamine-sur-Arve, 74130, France

Location

Groupe Hospitalier du Havre

Le Havre, 76083, France

Location

CHU de Limoges

Limoges, 87042, France

Location

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74370, France

Location

Hôpitaux du Léman

Thonon-les-Bains, 74200, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Pre-Eclampsia; HELLP Syndrome; Fetal Death; Eclampsia; Abruptio Placentae; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Placenta Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders

Study Officials

• Christophe DOCHE

  Centre Hospitalier Metropole Savoie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 6, 2018
• Study Start: January 10, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 31, 2019
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)