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Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia (APHERESE)

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ClinicalTrials.gov Identifier: NCT03188900
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
INSERM UMR-S 1139
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment
Preeclampsia Biological: A collection of maternal plasma and serum

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 [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 22 Weeks
Official Title: New Therapeutic Strategy Against Preeclampsia: Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : October 12, 2019
Estimated Study Completion Date : April 12, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
preeclampsia
pregnancy with preeclampsia
Biological: A collection of maternal plasma and serum
A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)

control
pregnancy without preeclampsia
Biological: A collection of maternal plasma and serum
A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)




Primary Outcome Measures :
  1. ratio sFlt-1/PlGF [ Time Frame: Day 0 ]
    measurement of of sFlT-1 and PlGF


Secondary Outcome Measures :
  1. Kinetics of these ratios sFlt-1/PlGF during pregnancy [ Time Frame: until 5 month ]
    measurement of of sFlT-1 and PlGF at many times


Biospecimen Retention:   Samples Without DNA
Blood


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnancy with preeclampsia and without preeclampsia
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188900


Contacts
Contact: Vassilis Tsatsaris, MD, PhD +33 1 58 41 38 71 vassilis.tsatsaris@aphp.fr
Contact: Laurence Lecomte, PhD +33 1 58 41 35 45 laurence.lecomte@aphp.fr

Locations
France
Hopital Cochin Recruiting
Paris, France, 75014
Contact: Vassilis Tsatsaris, MD, PhD    +33 1 58 41 38 71    vassilis.tsatsaris@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
INSERM UMR-S 1139
Investigators
Study Director: Edouard Lecarpentier, MD, PhD Centre Hospitalier Intercommunal de Créteil

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03188900     History of Changes
Other Study ID Numbers: SC3455
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Preeclampsia
apheresis
sflt-1

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications