Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia

NCT ID: NCT03188900

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-12

Study Completion Date

2019-06-12

Brief Summary

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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

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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

Conditions

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Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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preeclampsia

pregnancy with preeclampsia

A collection of maternal plasma and serum

Intervention Type BIOLOGICAL

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

control

pregnancy without preeclampsia

A collection of maternal plasma and serum

Intervention Type BIOLOGICAL

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

Interventions

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A collection of maternal plasma and serum

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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INSERM UMR-S 1139

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edouard Lecarpentier, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier intercommunal de Créteil

Locations

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Hopital Cochin

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 14602804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26405111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14764923 (View on PubMed)

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.

Reference Type RESULT
PMID: 31079531 (View on PubMed)

Other Identifiers

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SC3455

Identifier Type: -

Identifier Source: org_study_id

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