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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03981653
Other study ID # ANNOTEP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2019
Est. completion date March 2029

Study information

Verified date December 2022
Source Centre Hospitalier Intercommunal Creteil
Contact camille JUNG, MD
Phone 00157022268
Email camille.jung@chicreteil.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date March 2029
Est. primary completion date March 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier Intercommunal de Créteil Creteil

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of placental angiogenic factors Variation in the gene and protein expression of placental angiogenic factors on healthy placentas day 0
Secondary Level of sFlt-1 (Soluble FMS like tyrosin-kinase-1) Sflt-1 levels when the placenta is exposed to factors that promote the development of vascular pregnancy diseases day 1
Secondary Level of PlGF (Placental Growth Factor) PlGF levels when the placenta is exposed to factors that promote the development of vascular pregnancy diseases day 1
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