Study of the Platelet Function During the Last Month of Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: Blood sample

• Registration Number: NCT02828852
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-05
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregnancy	Blood sample	Blood sample
No pregnancy	Blood sample	Blood sample

Primary Outcome Measures

Name	Time	Method
surface covered by platelets	baseline	Percentage of surface covered by platelets (using the software Metamorph)
Volume of thrombies	baseline	Total volume of thrombies in μm3 (using the software Metamorph)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France