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NCT Number: NCT03981653

ANgiogenic Function at NOrmal TErm on Placenta

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location status: Recruiting

Location contact

Lecarpentier Edouard, MD

CONTACT

[email protected]

00145175543

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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 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 courses that may interfere with the biology of the trophoblast (immunomodulators in case of autoimmune diseases, anti-rejection drugs in case of transplant patients)

Treatment and study plan

Primary outcomes

  1. Level of placental angiogenic factors

    Time frame: day 0

    Variation in the gene and protein expression of placental angiogenic factors on healthy placentas

Secondary outcomes

  1. Level of sFlt-1 (Soluble FMS like tyrosin-kinase-1)

    Time frame: day 1

    Sflt-1 levels when the placenta is exposed to factors that promote the development of vascular pregnancy diseases

  2. Level of PlGF (Placental Growth Factor)

    Time frame: day 1

    PlGF levels when the placenta is exposed to factors that promote the development of vascular pregnancy diseases

Study contacts

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

camille JUNG, MD

CONTACT

[email protected]

00157022268

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Collaborators

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

Registry information

Acronym: ANNOTEP

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Jun 11, 2019
Registry last updated
Dec 21, 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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