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.

Pre-Eclampsia Clinical Trial

— PRECOPE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455387
• Other study ID #: CHMS16001
• Status: Completed
• Start date: January 10, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Metropole Savoie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 31, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patient who refuses the obstetric follow-up

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• sampling of the serum marker sFlt1 and PlGF
sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery

Locations

Country	Name	City	State
France	CHU de Brest	Brest
France	CHMetropoleSavoie	Chambéry	Savoie
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Metropole Savoie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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