Study of the Platelet Function During the Last Month of Pregnancy (VPI)

March 31, 2026 updated by: University Hospital, Toulouse

The objective is to compare women's platelet answer in the last month of pregnancy to women old enough to procreate, no pregnancy and without hormonal treatment.

The hypothesis of research is that the decrease of platelet answer in pregnant women could not only limit the occurence of embolic accidents but also explain the lowest incidence of the arterial thrombosis in comparison with the venous thrombosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a monocentric study comparing a group of pregnant women and a group of "no pregnancy" women.

The goal of the present study is to determine the impact of pregnancy on platelet function. For this, the study propose to explore, in women in the last month of pregnancy, the ability of platelets to aggregate after activation by strong agonists but also their ability to adhere to a matrix and form thrombies.

The study will include 30 pregnant and 30 "no pregnancy" control women, of childbearing age and not taking hormone therapy. From a blood sample, two types of examination will be implemented:

A) In whole blood, we will evaluate the percentage of platelet adhesion to collagen matrix or fibrinogen and the volume of thrombies formed.

B) In washed platelets and whole blood, we shall determine the percentage of aggregation after activation by different agonists and the amount of certain membrane markers of platelet activation. Furthermore, an assay of estradiol plasma will be made.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • France
      • Toulouse, France
        • University Hospital of Toulouse

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

Yes

Description

Inclusion Criteria:

  • Signature of the form of consent

  • Absence of any physical or psychic pathology which can interfere with the normal realization of the study

    • Group1 : Women in the last month of pregnancy
    • Group 2 : Women old enough to procreate, no pregnancy and without hormonal treatment

Exclusion Criteria:

  • Thrombopenia (platelet numeration < 120 000 / mm3),
  • Gestational diabet,
  • Hormonal treatment : oestrogen-progestagen, progestagen, Selective Estrogen Receptor Modulator (SERM), inductors of ovulation,
  • Anticoagulant and any medication which can intervene on the platelet function (AINS, antidepressants)
  • Personal history of thromboembolic accident venous or arterial,
  • Personal history of haemostasis disease
  • Personal history of hepatic or renal disease
  • Personal history of autoimmune disease.

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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregnancy
Blood sample
Other: Blood sample

In washed platelets and whole blood, study shall determine the percentage of aggregation after activation by different agonists and the amount of certain membrane markers of platelet activation. Furthermore, an assay of estradiol plasma will be made.

In whole blood, study will evaluate the percentage of platelet adhesion to collagen matrix or fibrinogen and the volume of thrombies formed.

Other Names:
  • Blood sample in pregnancy and no pregnancy women
Experimental: No pregnancy
Blood sample
Other: Blood sample

In washed platelets and whole blood, study shall determine the percentage of aggregation after activation by different agonists and the amount of certain membrane markers of platelet activation. Furthermore, an assay of estradiol plasma will be made.

In whole blood, study will evaluate the percentage of platelet adhesion to collagen matrix or fibrinogen and the volume of thrombies formed.

Other Names:
  • Blood sample in pregnancy and no pregnancy women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surface covered by platelets
Time Frame: baseline
Percentage of surface covered by platelets (using the software Metamorph)
baseline
Volume of thrombies
Time Frame: baseline
Total volume of thrombies in μm3 (using the software Metamorph)
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet aggregation
Time Frame: baseline
Percentage of platelet aggregation (whole blood and washed platelets)
baseline
chemokine Platelet Factor 4
Time Frame: baseline
Quantity of the chemokine Platelet Factor 4 (PF4) (IU/ml) secreted by the granules after activation by these agonists (washed platelets)
baseline
Thromboglobulin
Time Frame: baseline
Quantity of thromboglobulin (in ng / ml) secreted by the granules after activation by these agonists (washed platelets)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: PARANT Olivier, MD PhD, University Hospital, Toulouse

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

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

May 1, 2010

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimated)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09 163 02
  • Local Grant 2009 (Other Grant/Funding Number: 0916302)
  • 2010-A00082-37 (Other Identifier: French ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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