Study of Pregnancy Pathologies Associated With Placental Abnormalities

NCT05188066 | Not Yet Recruiting

• 1 other identifier: 38RC20.115
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre-eclampsia; Pre-Term; Fetal Growth Retardation

Keywords

pre-eclampsia; fetal growth retardation; placenta histology; vascularization; trophoblast proliferation

Outcome Measures

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.

  Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hours

Secondary Outcomes (1)

• 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.

Study Arms (2)

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

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

Interventions

Histology DIAGNOSTIC_TEST

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

Also known as: immunohistochemistry

Normal and pathological term; Normal, pathological IVG

Eligibility Criteria

• Age: 18 Years - 52 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include normal and pathological pregnant women from first to third trimester. A finaliser

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Placenta and fetal membrane from normal and pathological pregnancies

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth; Fetal Growth Retardation; Neovascularization, Pathologic

Interventions

Shadowing Technique, Histology; Immunohistochemistry

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metaplasia

Intervention Hierarchy (Ancestors)

Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Histocytochemistry; Immunologic Techniques

Study Officials

• Pascale Hoffmann, MD PHD

  Grenoble hospital

  PRINCIPAL INVESTIGATOR

• Nadia Alfaidy, PhD

  INSERM U1292

  STUDY DIRECTOR

Central Study Contacts

Pascale Hoffmann, MD PhD

CONTACT

0476769223; PHoffmann@chu-grenoble.fr

Nadia Alfaidy, PhD

CONTACT

0033632073234; nadia.alfaidy-benharouga@cea.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: January 12, 2022
• Study Start: January 6, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2030
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share