Study of Pregnancy Pathologies Associated With Placental Abnormalities
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-52
SponsorUniversity Hospital, Grenoble
About this trial
Pregnancy pathologies can occur from implantation until childbirth. The investigators are interested in the development mechanisms of these pathologies and aim to develop therapies to treat them.
The investigators need to collect samples, especially placental samples, following abortions and term and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for the understanding of the histological changes that occur in normal placentas collected at term of pregnancy. The latter will, in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of pre-eclampsia. This study will allow investigators to advance their understanding of the pathophysiological mechanisms of the placenta. The investigators are internationally recognized for their research on these pathologies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Admitted to the CHUGA for a birth or an abortion.
Pregnant women consenting to the collection of their fetal placenta membranes, during premature deliveries or at term of pregnancy OR Women performing an abortion consenting to the collection of their abortion products.
Having signed a consent
Affiliated with social security
Disqualifiers
Placental sample or abortion product unavailable (not collected or necessary for treatment).
Patient with known positive HIV or Hepatitis B or Hepatitis C serology or at risk according to the infectious safety criteria applied by the EFS.
hemoglobin <7d / dL or hemoglobin <10g / dL if she suffers from a cardio-respiratory pathology).
Patient protected by law (minor, hospitalized under duress, subject to a legal protection measure by guardianship or curatorship, deprived of liberty by judicial or administrative decision)
Trial population
The study will include normal and pathological pregnant women from first to third trimester. A finaliser
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Histology
Diagnostic testCollect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Normal, pathological IVG1 intervention
Group B: Normal and pathological term1 intervention
Trial outcomes
Primary outcomes
1
To better characterize pregnancy pathologies from implantation to childbirth
Comparison of the frequencies (in percentage) of the histological differences of the placenta and its appendages in patients with pathological and normal pregnancies (histological differences of normal pregnancies versus pathological pregnancies.
Time frame
Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hoursSecondary outcomes
1
Link between the frequencies of histological aberrations and worsening of the pathology
Comparison of the severity of the pathology according to the frequencies of aberrations
Time frame
Assessement of the link between the frequencies of histological aberrations and worsening of the pathology will be assessed on the final cohort; This will take up to 3 hours for each aberration.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Grenoble
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: