- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188900
Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia (APHERESE)
March 24, 2026 updated by: Assistance Publique - Hôpitaux de Paris
New Therapeutic Strategy Against Preeclampsia: Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Actual)
236
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75014
- Hopital Cochin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
pregnancy with preeclampsia and without preeclampsia
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control
pregnancy without preeclampsia
|
A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)
|
|
preeclampsia
pregnancy with preeclampsia
|
A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ratio sFlt-1/PlGF
Time Frame: Day 0
|
measurement of of sFlT-1 and PlGF
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinetics of these ratios sFlt-1/PlGF during pregnancy
Time Frame: until 5 month
|
measurement of of sFlT-1 and PlGF at many times
|
until 5 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Edouard Lecarpentier, MD, PhD, Centre Hospitalier Intercommunal de Créteil
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2017
Primary Completion (Actual)
June 12, 2019
Study Completion (Actual)
June 12, 2019
Study Registration Dates
First Submitted
April 13, 2017
First Submitted That Met QC Criteria
June 13, 2017
First Posted (Actual)
June 16, 2017
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 24, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC3455
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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