Clinical trial NCT05188066: Study of Pregnancy Pathologies Associated With Placental Abnormalities
Official title: Study of Pregnancy Pathologies Associated With Placental Abnormalities
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pre-eclampsia
Pre-Term
Fetal Growth Retardation
Keywords: pre-eclampsia
fetal growth retardation
placenta histology
vascularization
trophoblast proliferation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-01-12
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include normal and pathological pregnant women from first to third trimester. A finaliser

Brief summary: 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.

Detailed description: Pregnancy pathologies can occur from implantation until childbirth. Clinical and scientific investigators are interested in the study of the mechanisms of development of these pathologies and aim to develop therapies to treat them.

The investigators need to collect samples, especially placental samples, following abortions, 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 understanding 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 preeclampsia. This study will allow investigators to advance the understanding of the pathophysiological mechanisms of the placenta.

The investigators are internationally recognized for its research on these thematic.

Eligibility criteria: Inclusion Criteria:

Adult women

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: To better characterize pregnancy pathologies from implantation to childbirth
timeFrame: Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hours
Secondary outcomes:
measure: Link between the frequencies of histological aberrations and worsening of the pathology
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Grenoble hospital
name: Pascale Hoffmann, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM U1292
name: Nadia Alfaidy, PhD
role: STUDY_DIRECTOR
References: