CClinicalTrials.gg
CompletedNCT03455387PRECOPEUpdated Jun 14, 2022

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.

An observational study in Pre-Eclampsia, HELLP Syndrome and Fetal Death, sponsored by Centre Hospitalier Metropole Savoie. Completed at 7 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by Centre Hospitalier Metropole Savoie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
233
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • sFLt1
  • PlGF
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patient who refuses the obstetric follow-up
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
233 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testsampling of the serum marker sFlt1 and PlGF

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

05

What researchers measure

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.

    Time frame: during the pregnancy from 24 weeks of gestation until delivery

06

Study locations

7 sites
  • CHMetropoleSavoie
    Chambéry, Savoie 73000, France
  • CHU de Brest
    Brest, 29200, France
  • Centre Hospitalier Alpes Léman
    Contamine-sur-Arve, 74130, France
  • Groupe Hospitalier du Havre
    Le Havre, 76083, France
  • CHU de Limoges
    Limoges, 87042, France
  • Centre Hospitalier Annecy Genevois
    Metz-Tessy, 74370, France
  • Hôpitaux du Léman
    Thonon-les-Bains, 74200, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03455387
Lead sponsor
Centre Hospitalier Metropole Savoie
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Jan 10, 2017
Primary completion
Dec 20, 2019
Completion
Dec 31, 2019
Last update
Jun 14, 2022

Study contacts

Christophe DOCHE
study director · Centre Hospitalier Metropole Savoie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion