Clinical trial NCT03981653: ANgiogenic Function at NOrmal TErm on Placenta
Official title: Angiogenic Function at Normal Term on Placenta
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-06-11
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a progressive, full-term pregnancy

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.

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)

Primary outcomes:
measure: Level of placental angiogenic factors
timeFrame: day 0
Secondary outcomes:
measure: Level of sFlt-1 (Soluble FMS like tyrosin-kinase-1)
timeFrame: day 1
measure: Level of PlGF (Placental Growth Factor)
timeFrame: day 1
Other outcomes:
Locations:
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
Study officials:
References: