Immune Thrombocytopenia, Pregnancy
Conditions
Keywords
Immune Thrombocytopenia, Pregnancy
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.
Interventions
OTHERNo intervention
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | 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 |
Countries
France
Contacts
Primary ContactBertrand Godeau, PU-PH
Backup ContactValentine Loustau, CCA
Outcome results
None listed