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NCT Number: NCT05188066

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Histology

Diagnostic Test

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

Other names: immunohistochemistry

Primary outcomes

  1. To better characterize pregnancy pathologies from implantation to childbirth

    Time frame: 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 outcomes

  1. Link between the frequencies of histological aberrations and worsening of the pathology

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Alfaidy, PhD

CONTACT

[email protected]

0033632073234

Pascale Hoffmann, MD PhD

CONTACT

[email protected]

0476769223

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
Jan 12, 2022
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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