Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID05675969

Study of Microvesicles in Pre-eclampsia in Women With Threatened Preterm Delivery

Led by University Hospital, Bordeaux · Updated on 2025-02-10

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Bordeaux

Lead Sponsor

U

University of Bordeaux

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the role of microvesicles (MVs), which are small membrane fragments released by cells, in pregnant women with and without pre-eclampsia. These MVs, especially those from the placenta, may have effects related to blood clotting, immune response, and blood vessel growth, which are important in pre-eclampsia. The study aims to compare the total concentration of main MV populations in the blood of women diagnosed with pre-eclampsia to those without the condition. Participants will have two additional tubes of blood collected during routine care visits close to the time of diagnosis or matching. The study groups include women with severe pre-eclampsia before 32 weeks of pregnancy and women without pre-eclampsia but hospitalized for threatened preterm delivery. Blood samples will be analyzed using advanced techniques developed by the research team to identify and measure different types of MVs. During the study, participants provide blood samples that are used to measure the concentration of various MVs, including those originating from red blood cells, platelets, and the placenta. Researchers will also track related clinical factors such as gravidic hypertension. The study is non-randomized and no masking is used. Participation involves routine blood collection aligned with standard care, and the main outcome measured is the total concentration of MVs in maternal blood at baseline.

CONDITIONS

Brief Title

Pilot Study of Microvesicles in Pre-eclamptic and Non-pre-eclamptic Women With Threatened Preterm Delivery

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Singleton pregnancy or spontaneously reduced twin pregnancy before 14 weeks gestation
  • Gestational age between 23 and 31 weeks and 6 days at inclusion
  • Patient provides non-opposition consent
  • Affiliated with or beneficiary of a social security system
  • For non-pre-eclampsia group: hospitalized for isolated threat of preterm delivery without maternal fever (temperature < 38.0°C) or biological markers of inflammation (CRP < 5)
  • For pre-eclampsia group: diagnosis of severe pre-eclampsia before 32 weeks' gestation
Not Eligible

You will not qualify if you...

  • Inability to understand the study or refusal to give consent
  • Under legal protection

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - At diagnosis or matching routine care visit

Participants provide blood samples during routine care for analysis of microvesicles related to pre-eclampsia status.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

CHU Bordeaux

Bordeaux, France

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Research Team

L

Loic Sentilhes, MD, PhD

A

Alain Brisson, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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