Immune Thrombocytopenia in Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Immune Thrombocytopenia in Pregnancy: Evolution and Prognostic Factors According to a Prospective Observational Comparative Multicenter National French Study

Conditions
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Immune Thrombocytopenia, Pregnancy

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The biologic worsening is defined by a platelet decrease > 30% compared to platelet count before pregnancy | During 15 months (9 months of pregnancy and 6 months of post partum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of risk factors of ITP worsening during pregnancy |  | During 15 months | 
| Evaluation of obstetrical complications in case of ITP |  | During 15 months | 
| Evaluation of neonatal thrombocytopenia in case of maternal ITP |  | During 15 months | 
| Identification of the risk factors of obstetrical complications |  | During 15 months | 
| Identification of the risk factors of neonatal thrombocytopenia |  | During 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune Thrombocytopenia, Pregnancy