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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03455387

Acronym

PRECOPE

Enrollment

233

Registered

2018-03-06

Start date

2017-01-10

Completion date

2019-12-31

Last updated

2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

sFLt1, PlGF

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.

Interventions

DIAGNOSTIC_TESTsampling of the serum marker sFlt1 and PlGF

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* patient who refuses the obstetric follow-up

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026