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Study of the Platelet Function During the Last Month of Pregnancy

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ClinicalTrials.gov Identifier: NCT02828852
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pregnancy Other: Blood sample Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of the Platelet Function During the Last Month of Pregnancy
Study Start Date : May 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

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 Name: 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 Name: Blood sample in pregnancy and no pregnancy women




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828852


Locations
France
University Hospital of Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: PARANT Olivier, MD PhD University Hospital, Toulouse

Publications of Results:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02828852     History of Changes
Other Study ID Numbers: 09 163 02
Local Grant 2009 ( Other Grant/Funding Number: 0916302 )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:
pregnancy
platelets