Study of Pregnancy Pathologies Associated With Placental Abnormalities

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05188066

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

800

Enrollment

96.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-eclampsia Pre-Term Fetal Growth Retardation	Diagnostic Test: Histology

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 Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of Pregnancy Pathologies Associated With Placental Abnormalities

Anticipated Study Start Date :

Jan 6, 2022

Anticipated Primary Completion Date :

Jan 31, 2027

Anticipated Study Completion Date :

Jan 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Normal, pathological IVG We will use placenta and fetal memebranes collected from first trimester termination of pregnancy. This will constitute group IVG.	Diagnostic Test: Histology Collect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses Other Names: immunohistochemistry
Normal and pathological term We will also use the same specimens collected from third trimester pregnancies . We will call this group normal and pathological..... à finaliser	Diagnostic Test: Histology Collect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses Other Names: immunohistochemistry

Arm

Intervention/Treatment

Normal, pathological IVG

We will use placenta and fetal memebranes collected from first trimester termination of pregnancy. This will constitute group IVG.

Diagnostic Test: Histology

Collect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses

Other Names:

immunohistochemistry

Normal and pathological term

We will also use the same specimens collected from third trimester pregnancies . We will call this group normal and pathological..... à finaliser

Diagnostic Test: Histology

Collect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses

Other Names:

immunohistochemistry

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 52 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)