Study of the Platelet Function During the Last Month of Pregnancy

Pregnancy Clinical Trial

Official title:

Study of the Platelet Function During the Last Month of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828852
• Other study ID #: 09 163 02
• Secondary ID: Local Grant 2009
• Status: Completed
• Phase: N/A
• First received: July 4, 2016
• Last updated: May 10, 2017
• Start date: May 2010
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Valéra MC, Parant O, Cenac C, Arnaud C, Gallini A, Hamdi S, Sié P, Arnal JF, Payrastre B. Platelet Adhesion and Thrombus Formation in Whole Blood at Arterial Shear Rate at the End of Pregnancy. Am J Reprod Immunol. 2015 Dec;74(6):533-41. doi: 10.1111/aji. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surface covered by platelets	Percentage of surface covered by platelets (using the software Metamorph)	baseline
Primary	Volume of thrombies	Total volume of thrombies in µm3 (using the software Metamorph)	baseline
Secondary	Platelet aggregation	Percentage of platelet aggregation (whole blood and washed platelets)	baseline
Secondary	chemokine Platelet Factor 4	Quantity of the chemokine Platelet Factor 4 (PF4) (IU/ml) secreted by the granules after activation by these agonists (washed platelets)	baseline
Secondary	Thromboglobulin	Quantity of thromboglobulin (in ng / ml) secreted by the granules after activation by these agonists (washed platelets)	baseline