Immune Thrombocytopenia in Pregnancy

Assistance Publique - Hôpitaux de Paris300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Immune Thrombocytopenia Pregnancy

Interventions

No interventionOTHER

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: During 15 months (9 months of pregnancy and 6 months of post partum)

Secondary Outcomes

Identification of risk factors of ITP worsening during pregnancy

Time frame: During 15 months

Evaluation of obstetrical complications in case of ITP

Time frame: During 15 months

Evaluation of neonatal thrombocytopenia in case of maternal ITP

Time frame: During 15 months

Identification of the risk factors of obstetrical complications

Time frame: During 15 months

Identification of the risk factors of neonatal thrombocytopenia

Time frame: During 15 months

Immune Thrombocytopenia in Pregnancy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts