Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia

Completed

• Conditions: Preeclampsia
• Interventions: Biological: A collection of maternal plasma and serum

• Registration Number: NCT03188900
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2017-04-13
• Study Start: 2017-06-12
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-16
• Primary Completion: 2019-06-12
• Study Completion: 2019-06-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 236

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	A collection of maternal plasma and serum	pregnancy without preeclampsia
preeclampsia	A collection of maternal plasma and serum	pregnancy with preeclampsia

Primary Outcome Measures

Name	Time	Method
ratio sFlt-1/PlGF	Day 0	measurement of of sFlT-1 and PlGF

Secondary Outcome Measures

Name	Time	Method
Kinetics of these ratios sFlt-1/PlGF during pregnancy	until 5 month	measurement of of sFlT-1 and PlGF at many times

Trial Locations

Locations (1)

Hopital Cochin; 🇫🇷 Paris, France