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NCT05142410Completed

Understanding Post-translational Modifications to Circulating Histones Via Mass Spectrometry in Pregnant Women Developing Pre-eclampsia: A Retrospective Study

A Retrospective Study Using Mass Spectrometry to Characterize Post-translational Modifications to Circulating Histones in Pregnant Women Developing Pre-eclampsia

Source: ClinicalTrials.gov · Last updated 31 Jan 2024

Brief summary (registry, in English)

This is a descriptive pilot study on a ready-constituted biobank (outside the Jardé Law). It is an ancillary study to the "GrossPath" cohort (RCB ID number: 2014-A01120-47). Pregnancy generates an increased risk of thrombosis, and placenta-mediated diseases constitute a risk factor for cardiovascular pathologies responsible for significant maternal-fetal morbidity and mortality. Understanding and exploring the cellular and molecular mechanisms of dysfunctions of the vascular-placental interface could provide arguments to understand the systemic vascular risk, characterize it and finally detect it on the basis of new markers, thus opening the way for targeted preventive management to reinforce the general principles of precision medicine. Netosis is a process of activation of neutrophils, which then generate filaments containing DNA, enzymes and extracellular histones. Netosis occurs in pregnancy and is increased in vascular-placental complications. It can be studied by measuring circulating histones, particularly the citrullinated histone H3. Levels of this modified histone H3, as well as those of two other modifications, have recently been shown to increase during pregnancy. These levels have also been shown to be even greater in pregnancy complications. The aim of this study is to complete this mapping in order to obtain a precise signature for all post-translational histone modifications in normal pregnancies and pregnancies complicated by pre-eclampsia from the "GrossPath" cohort in order to propose new circulating biomarkers for placental vascular pathologies. The post-translational histone modification profiles (mapping) of pregnant women with normal pregnancies will be compared with those developing pre-eclampsia.

Status (registry)
Completed
Study type
Observational
Enrollment
28 (actual)
First submitted
18 Nov 2021
Start date
1 Mar 2019
Primary completion date
30 Nov 2020
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
NCT number
NCT05142410

What you commit to

  • Study type: Observational
  • Participants enrolled: 28
  • From 1 Mar 2019 to the primary completion date, 30 Nov 2020
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Not applicable as this is a study on samples from a biobank. The non-inclusion criteria of the "GrossPath" cohort were :
  • twin pregnancies.

Who the study is looking for

  • Not applicable as this study is on samples from a biobank. The inclusion criteria for the "GrossPath" cohort were:
  • pregnant women followed at Nîmes University hospital for normal pregnancy or pregnancy with placental vascular pathology (pre-eclampsia and/or intra-uterine growth retardation).
  • The patient must have given her free and informed consent and signed the consent form.
  • The patient must be a member or beneficiary of a health insurance plan
  • Only women are included
  • Patients are at least 18 years old

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nîmes University Hospital
Coordinator of this site? Confirm its status
NîmesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.