ANgiogenic Function at NOrmal TErm on Placenta

Pregnancy Related Clinical Trial

— ANNOTEP  

Official title:

Angiogenic Function at Normal Term on Placenta

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981653
• Other study ID #: ANNOTEP
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Pregnancy Related

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