Clinical Trial: Immune Thrombocytopenia in Pregnancy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: July 31, 2016
Date Started: January 2014
Date Completion: April 2018
Last Updated: September 1, 2016
Last Verified: July 2016