Clinical trial NCT02828852: Study of the Platelet Function During the Last Month of Pregnancy
Official title: Study of the Platelet Function During the Last Month of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pregnancy
platelets
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: surface covered by platelets
timeFrame: baseline
measure: Volume of thrombies
timeFrame: baseline
Secondary outcomes:
measure: Platelet aggregation
timeFrame: baseline
measure: chemokine Platelet Factor 4
timeFrame: baseline
measure: Thromboglobulin
timeFrame: baseline
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: PARANT Olivier, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valera MC, Parant O, Cenac C, Arnaud C, Gallini A, Hamdi S, Sie 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.12433. Epub 2015 Oct 4.