ANgiogenic Function at NOrmal TErm on Placenta

Last updated: December 20, 2022
Sponsor: Centre Hospitalier Intercommunal Creteil
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03981653
ANNOTEP
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

In vivo and ex vivo study of trophoblastic angiogenic trophoblastic function in placentas from normal pregnancies, at term

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnancies with scheduled cesarean delivery >37 weeks of amenorrhea:
  • strictly normal pregnancies
  • complicated pregnancies of gestational diabetes, insulin-treated or not
  • complicated pregnancies due to pregnancy cholestasis
  • spontaneous or in vitro fecondation (IVF) / Intracytoplasmic sperm injection (ICSI)pregnancies with or without oocyte donation

Exclusion

Exclusion Criteria:

  • Patient's opposition
  • Age < 18 years old
  • Women under the protection of justice
  • Multiple pregnancy
  • Known major fetal malformation
  • Pre-eclampsia and intrauterine growth retardation
  • Placental insertionnomaly
  • Type 1 diabetes
  • HIV-positive patient with HIV/hepatisis C virus (HCV) regardless of viral load
  • Patient in labour at the time of Caesarean section
  • Patient whose medical history results in medication being taken in pregnancy coursesthat may interfere with the biology of the trophoblast (immunomodulators in case ofautoimmune diseases, anti-rejection drugs in case of transplant patients)

Study Design

Total Participants: 750
Study Start date:
March 20, 2019
Estimated Completion Date:
March 31, 2029

Study Description

The objective of this study is to better understand the regulation of trophoblast expression of pro- and antiangiogenic factors such as placenta growth factor (PlGF) or Soluble FMS like tyrosin-kinase-1 (sFlt-1), and more particularly on human differentiated trophoblastic cells from "healthy" placentas. The measurement of the variation in gene and protein expression of placental angiogenic factors will provide a better understanding of their pathophysiology.

Secondary objectives are the study of trophoblastic differentiation and placental functions, and the study of the impact of chemical compounds on the biological functions of the placenta. To do this, these "healthy" placentas may be exposed to different factors that promote the occurrence of specific pregnancy pathologies such as pre-eclampsia and vascular intrauterine growth restriction (IUGR), caused by placental dysfunction. This will make it possible to test molecules and vector approaches targeted directly at the trophoblast, in order to consider therapeutic targets, which do not exist to date.

Connect with a study center

  • Centre Hospitalier Intercommunal de Créteil

    Creteil, 94000
    France

    Active - Recruiting

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