Study of Pregnancy Pathologies Associated With Placental Abnormalities

Pre-eclampsia Clinical Trial

Official title:

Study of Pregnancy Pathologies Associated With Placental Abnormalities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05188066
• Other study ID #: 38RC20.115
• Status: Not yet recruiting
• Start date: January 6, 2022
• Est. completion date: January 31, 2030

Study information

• Verified date: January 2022
• Source: University Hospital, Grenoble
• Contact: Pascale Hoffmann, MD PhD
• Phone: 0476769223
• Email: PHoffmann[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: January 31, 2030
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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)

Related Conditions & MeSH terms

• Eclampsia
• Fetal Growth Retardation
• Pre-eclampsia
• Pre-Term

Intervention

Diagnostic Test:
• Histology
Collect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.