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Completed

NCT Number: NCT02828852

Study of the Platelet Function During the Last Month of Pregnancy

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

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

Primary outcomes

  1. surface covered by platelets

    Time frame: baseline

    Percentage of surface covered by platelets (using the software Metamorph)

  2. Volume of thrombies

    Time frame: baseline

    Total volume of thrombies in μm3 (using the software Metamorph)

Secondary outcomes

  1. Platelet aggregation

    Time frame: baseline

    Percentage of platelet aggregation (whole blood and washed platelets)

  2. 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)

  3. Thromboglobulin

    Time frame: baseline

    Quantity of thromboglobulin (in ng / ml) secreted by the granules after activation by these agonists (washed platelets)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: VPI

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jul 12, 2016
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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