Clinical trial NCT03188900: Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia
Official title: New Therapeutic Strategy Against Preeclampsia: Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Preeclampsia
apheresis
sflt-1
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: INSERM UMR-S 1139
First posted: 2017-06-16
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnancy with preeclampsia and without preeclampsia

Brief summary: The aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sFlt-1

Detailed description: A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP) :

* Between 20WG and 23WG+6D : 20 patients with PE and 30 patients with NP
* Between 24WG and 27WG+6D : 20 patients with PE and 30 patients with NP
* Between 28WG and 31WG+6D : 20 patients with PE and 30 patients with NP
* Between 32WG and 35WG+6D : 20 patients with PE and 30 patients with NP
* Between 36WG and 40WG+6D : 20 patients with PE and 30 patients with NP

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 50 years old
* Singleton pregnancies between 20 and 41 weeks of gestation
* Preeclampsia
* Normal pregnancy

Exclusion Criteria:

* Age\<18
* Infectious disease: HIV, HBV or HCV
* Multiple pregnancies
* Opposition of the patient

Primary outcomes:
measure: ratio sFlt-1/PlGF
timeFrame: Day 0
Secondary outcomes:
measure: Kinetics of these ratios sFlt-1/PlGF during pregnancy
timeFrame: until 5 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Cochin
Study officials:
affiliation: Centre Hospitalier intercommunal de Créteil
name: Edouard Lecarpentier, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Tsatsaris V, Goffin F, Munaut C, Brichant JF, Pignon MR, Noel A, Schaaps JP, Cabrol D, Frankenne F, Foidart JM. Overexpression of the soluble vascular endothelial growth factor receptor in preeclamptic patients: pathophysiological consequences. J Clin Endocrinol Metab. 2003 Nov;88(11):5555-63. doi: 10.1210/jc.2003-030528.
citation: Thadhani R, Hagmann H, Schaarschmidt W, Roth B, Cingoez T, Karumanchi SA, Wenger J, Lucchesi KJ, Tamez H, Lindner T, Fridman A, Thome U, Kribs A, Danner M, Hamacher S, Mallmann P, Stepan H, Benzing T. Removal of Soluble Fms-Like Tyrosine Kinase-1 by Dextran Sulfate Apheresis in Preeclampsia. J Am Soc Nephrol. 2016 Mar;27(3):903-13. doi: 10.1681/ASN.2015020157. Epub 2015 Sep 24.
citation: Levine RJ, Maynard SE, Qian C, Lim KH, England LJ, Yu KF, Schisterman EF, Thadhani R, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83. doi: 10.1056/NEJMoa031884. Epub 2004 Feb 5.
citation: Trapiella-Alfonso L, Alexandre L, Fraichard C, Pons K, Dumas S, Huart L, Gaucher JF, Hebert-Schuster M, Guibourdenche J, Fournier T, Vidal M, Broutin I, Lecomte-Raclet L, Malaquin L, Descroix S, Tsatsaris V, Gagey-Eilstein N, Lecarpentier E. VEGF (Vascular Endothelial Growth Factor) Functionalized Magnetic Beads in a Microfluidic Device to Improve the Angiogenic Balance in Preeclampsia. Hypertension. 2019 Jul;74(1):145-153. doi: 10.1161/HYPERTENSIONAHA.118.12380. Epub 2019 May 13.