ANgiogenic Function at NOrmal TErm on Placenta
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy Related. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Angiogenic Function at Normal Term on Placenta
Overview
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.
Primary outcome measures
- Level of placental angiogenic factors [Time frame: day 0]
Secondary outcome measures (2)
- Level of sFlt-1 (Soluble FMS like tyrosin-kinase-1) [Time frame: day 1]
- Level of PlGF (Placental Growth Factor) [Time frame: day 1]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre Hospitalier Intercommunal de Créteil — Créteil
Identifiers
NCT: NCT03981653 · ANNOTEP