Immune Thrombocytopenia in Pregnancy
- Conditions
- Immune ThrombocytopeniaPregnancy
- Interventions
- Other: No intervention
- Registration Number
- NCT02892630
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control ITP Women (Non pregnant) No intervention Primary ITP women more than 18 years old, at more than one year from a precedent pregnancy Pregnant ITP women No intervention Pregnant women more than 18 years old, with primary ITP diagnosis before pregnancy De novo ITP pregnant women No intervention Pregnant women more than 18 years old, with newly diagnosed thrombocytopenia during pregnancy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Henri Mondor Hospital
🇫🇷Creteil, France