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Immune Thrombocytopenia in Pregnancy (TIGRO)

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ClinicalTrials.gov Identifier: NCT02892630
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The pregnancy may activate flares of certain autoimmune diseases such as lupus. The influence of pregnancy on the evolution of ITP was never studied while this pathology affects firstly women old enough to procreate. Also, the influence of ITP on pregnancy (risk of obstetric complications) and on newborns (risk of neonatal thrombocytopenia) is rather unknown and never studied in a prospective study. The realization of a prospective study to answer these questions is necessary to allow us to inform better the patients affected by ITP and to define better in this context the strategy of supervision of the mother, the foetus and the newborn. The highlighting of risk factors of ITP flare or obstetric or neonatal complications will indeed allow the implementation of prevention measures.

The conclusions of this study will allow us to adapt national guidelines for ITP during pregnancy.


Condition or disease Intervention/treatment
Immune Thrombocytopenia Pregnancy Other: No intervention

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Thrombocytopenia in Pregnancy: Evolution and Prognostic Factors According to a Prospective Observational Comparative Multicenter National French Study
Actual Study Start Date : February 3, 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


Group/Cohort Intervention/treatment
Pregnant ITP women
Pregnant women more than 18 years old, with primary ITP diagnosis before pregnancy
Other: No intervention
Control ITP Women (Non pregnant)
Primary ITP women more than 18 years old, at more than one year from a precedent pregnancy
Other: No intervention
De novo ITP pregnant women
Pregnant women more than 18 years old, with newly diagnosed thrombocytopenia during pregnancy
Other: No intervention



Primary Outcome Measures :
  1. Composite criteria including in the two principal groups (pregnant and none pregnant) : Frequency of: - ITP treatment modification,- biologic worsening and severe thrombocytopenia (<30G/L), - hemorrhagic complication and ITP status modification [ Time Frame: During 15 months (9 months of pregnancy and 6 months of post partum) ]
    The biologic worsening is defined by a platelet decrease > 30% compared to platelet count before pregnancy


Secondary Outcome Measures :
  1. Identification of risk factors of ITP worsening during pregnancy [ Time Frame: During 15 months ]
  2. Evaluation of obstetrical complications in case of ITP [ Time Frame: During 15 months ]
  3. Evaluation of neonatal thrombocytopenia in case of maternal ITP [ Time Frame: During 15 months ]
  4. Identification of the risk factors of obstetrical complications [ Time Frame: During 15 months ]
  5. Identification of the risk factors of neonatal thrombocytopenia [ Time Frame: During 15 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from French referral centers for immune Thrombocytopenia
Criteria
  1. Pregnant ITP women Inclusion Criteria

    • Women more than 18 years old
    • Primary ITP diagnosis, defined according to international criteria of 2009 consensus conference (isolated thrombocytopenia <100 G/L)
    • And pregnancy diagnosis after ITP diagnosis
    • Information notice delivered to women with non opposition to participation to the study Exclusion Criteria
    • Secondary ITP (according to 2009 consensus conference)
    • Severe comorbidity making difficult women's following
  2. Control ITP Women (Non pregnant) Inclusion Criteria

    • Women more than 18 years old
    • Primary ITP diagnosis, defined according to international criteria of 2009 consensus conference (isolated thrombocytopenia <100 G/L)
    • Non pregnant (> 12 months of precedent pregnancy)
    • (Matched on age+/- 5 years old: suppress by amendment n°3 20170117), phase and status of ITP, and history of splenectomy
    • Information notice delivered to women with non opposition to participation to the study Exclusion Criteria
    • Secondary ITP (according to 2009 consensus conference)
    • Severe comorbidity making difficult women's following
  3. De novo ITP pregnant women Inclusion Criteria

    • Women more than 18 years old
    • Pregnant
    • With a newly diagnosed thrombocytopenia <50G/L, after elimination of others thrombocytopenia etiologies during pregnancy: gestational thrombocytopenia, preeclampsia, HELLP syndrome, ….
    • Information notice delivered to women with non opposition to participation to the study Exclusion Criteria
    • Secondary ITP (according to 2009 consensus conference)
    • Severe comorbidity making difficult women's following
    • Non confirmation of ITP diagnosis in post-partum

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): NCT02892630


Contacts
Contact: Bertrand Godeau, PU-PH (0)1 49 81 29 05 ext +33 bertrand.godeau@hmn.aphp.fr
Contact: Valentine Loustau, CCA (0)1 49 81 20 76 ext +33 valentine.loustau@hmn.aphp.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Bertand Godeau, PU-PH    (0)1 49 81 29 05 ext +33    bertrand.godeau@hmn.aphp.fr   
Contact: Valentine Loustau, CCA    (0)1 49 81 20 76 ext +33    valentine.loustau@hmn.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Bertrand Godeau, PU-PH Assistance Publique - Hôpitaux de Paris

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02892630     History of Changes
Other Study ID Numbers: AOM12204
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Immune Thrombocytopenia
Pregnancy

Additional relevant MeSH terms:
Autoimmune Diseases
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms