NCT03188900

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

April 13, 2017

Last Update Submit

March 24, 2026

Conditions

Preeclampsia

Keywords

Preeclampsiaapheresissflt-1

Outcome Measures

Primary Outcomes (1)

  • ratio sFlt-1/PlGF

    measurement of of sFlT-1 and PlGF

    Day 0

Secondary Outcomes (1)

  • Kinetics of these ratios sFlt-1/PlGF during pregnancy

    until 5 month

Study Arms (2)

preeclampsia

pregnancy with preeclampsia

Biological: A collection of maternal plasma and serum

control

pregnancy without preeclampsia

Biological: A collection of maternal plasma and serum

Interventions

A collection of maternal plasma and serumBIOLOGICAL

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

controlpreeclampsia

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnancy with preeclampsia and without preeclampsia

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75014, France

Location

Related Publications (4)

  • 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.

    PMID: 14602804BACKGROUND

  • 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.

    PMID: 26405111BACKGROUND

  • 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.

    PMID: 14764923BACKGROUND

  • 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.

    PMID: 31079531RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Edouard Lecarpentier, MD, PhD

    Centre Hospitalier intercommunal de Créteil

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
22 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

June 16, 2017

Study Start

June 12, 2017

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)