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)

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.

Study Overview

• Status: Completed
• Conditions: Eclampsia; Pre-Eclampsia; HELLP Syndrome; Fetal Death; Placental Abruption; Fetal Growth Retardation, Antenatal
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHU de Brest
  • Contamine-sur-Arve, France, 74130
    • Centre Hospitalier Alpes Léman
  • Le Havre, France, 76083
    • Groupe Hospitalier Du Havre
  • Limoges, France, 87042
    • CHU de Limoges
  • Metz-Tessy, France, 74370
    • Centre Hospitalier Annecy Genevois
  • Thonon-les-Bains, France, 74200
    • Hôpitaux du Léman
  • Savoie
    • Chambéry, Savoie, France, 73000
      • CHMetropoleSavoie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Metropole Savoie
• Investigators: Study Director: Christophe DOCHE, Centre Hospitalier Métropole Savoie

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: PlGF; sFLt1
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Death; Hypertension, Pregnancy-Induced; Growth Disorders; Eclampsia; Pre-Eclampsia; Fetal Growth Retardation; HELLP Syndrome; Fetal Death; Abruptio Placentae
• Other Study ID Numbers: CHMS16001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No