NCT02828852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

6.2 years

First QC Date

July 4, 2016

Last Update Submit

May 10, 2017

Conditions

Pregnancy

Keywords

pregnancyplatelets

Outcome Measures

Primary Outcomes (2)

  • surface covered by platelets

    Percentage of surface covered by platelets (using the software Metamorph)

    baseline

  • Volume of thrombies

    Total volume of thrombies in μm3 (using the software Metamorph)

    baseline

Secondary Outcomes (3)

  • Platelet aggregation

    baseline

  • chemokine Platelet Factor 4

    baseline

  • Thromboglobulin

    baseline

Study Arms (2)

Pregnancy

EXPERIMENTAL

Blood sample

Other: Blood sample

No pregnancy

EXPERIMENTAL

Blood sample

Other: Blood sample

Interventions

Blood sampleOTHER

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.

Also known as: Blood sample in pregnancy and no pregnancy women
No pregnancyPregnancy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

Related Publications (1)

  • 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.

    PMID: 26435170RESULT

MeSH Terms

Interventions

Blood Specimen CollectionPregnancy

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • PARANT Olivier, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 12, 2016

Study Start

May 1, 2010

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)