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Study of the Platelet Function During the Last Month of Pregnancy

T

Toulouse University Hospital

Status

Completed

Conditions

Pregnancy

Treatments

Other: Blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT02828852
Local Grant 2009 (Other Grant/Funding Number)
09 163 02

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Pregnancy
Experimental group
Description:
Blood sample
Treatment:
Other: Blood sample
No pregnancy
Experimental group
Description:
Blood sample
Treatment:
Other: Blood sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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