ANgiogenic Function at NOrmal TErm on Placenta

NCT ID: NCT03981653

Last Updated: 2022-12-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2029-03-31

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.

Conditions

Pregnancy Related

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Site Status: RECRUITING

Countries

France

Central Contacts

camille JUNG, MD

Role: CONTACT

camille.jung@chicreteil.fr

00157022268

Facility Contacts

Lecarpentier Edouard, MD

Role: primary

edouard.lecarpentier@chicreteil.fr

00145175543

Other Identifiers

ANNOTEP

Identifier Type: -

Identifier Source: org_study_id