Study of Pregnancy Pathologies Associated With Placental Abnormalities

Not yet recruiting

• Conditions: Pre-eclampsia; Pre-Term; Fetal Growth Retardation
• Interventions: Diagnostic Test: Histology

• Registration Number: NCT05188066
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2021-12-18
• Status Verified: 2022-01
• Study Start: 2022-01-06
• Study First Submitted QC: 2022-01-07
• Last Update Submitted: 2022-01-07
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12
• Primary Completion: 2027-01-31
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 800

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal and pathological term	Histology	We will also use the same specimens collected from third trimester pregnancies . We will call this group normal and pathological..... à finaliser
Normal, pathological IVG	Histology	We will use placenta and fetal memebranes collected from first trimester termination of pregnancy. This will constitute group IVG.

Primary Outcome Measures

Name	Time	Method
To better characterize pregnancy pathologies from implantation to childbirth	Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hours	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.

Secondary Outcome Measures

Name	Time	Method
Link between the frequencies of histological aberrations and worsening of the pathology	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.	Comparison of the severity of the pathology according to the frequencies of aberrations