Study of Pregnancy Pathologies Associated With Placental Abnormalities

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fetal Growth Retardation; Pre-eclampsia; Pre-Term
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Pascale Hoffmann, MD PhD; Phone Number: 0476769223; Email: PHoffmann@chu-grenoble.fr
• Study Contact Backup: Name: Nadia Alfaidy, PhD; Phone Number: 0033632073234; Email: nadia.alfaidy-benharouga@cea.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 52 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Pascale Hoffmann, MD PHD, Grenoble Hospital; Study Director: Nadia Alfaidy, PhD, INSERM U1292

Study record dates

Study Major Dates

• Study Start (Anticipated): January 6, 2022
• Primary Completion (Anticipated): January 31, 2027
• Study Completion (Anticipated): January 31, 2030

Study Registration Dates

• First Submitted: December 18, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: pre-eclampsia; vascularization; fetal growth retardation; placenta histology; trophoblast proliferation
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Growth Disorders; Eclampsia; Pre-Eclampsia; Fetal Growth Retardation
• Other Study ID Numbers: 38RC20.115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No