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ANgiogenic Function at NOrmal TErm on Placenta

Angiogenic Function at Normal Term on Placenta

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03981653
Acronym
ANNOTEP
Enrollment
750
Registered
2019-06-11
Start date
2019-03-20
Completion date
2029-03-31
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

Brief summary

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

Detailed 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.

Interventions

None listed

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Level of placental angiogenic factorsday 0Variation in the gene and protein expression of placental angiogenic factors on healthy placentas

Secondary

MeasureTime frameDescription
Level of sFlt-1 (Soluble FMS like tyrosin-kinase-1)day 1Sflt-1 levels when the placenta is exposed to factors that promote the development of vascular pregnancy diseases
Level of PlGF (Placental Growth Factor)day 1PlGF levels when the placenta is exposed to factors that promote the development of vascular pregnancy diseases

Countries

France

Contacts

Primary Contactcamille JUNG, MD
camille.jung@chicreteil.fr00157022268

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026