Immune Thrombocytopenia in Pregnancy (TIGRO)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Immune Thrombocytopenia; Pregnancy

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02892630

AOM12204

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

300 participants in 3 patient groups

Pregnant ITP women

Description:

Pregnant women more than 18 years old, with primary ITP diagnosis before pregnancy

Treatment:

Other: No intervention

Control ITP Women (Non pregnant)

Description:

Primary ITP women more than 18 years old, at more than one year from a precedent pregnancy

Treatment:

Other: No intervention

De novo ITP pregnant women

Description:

Pregnant women more than 18 years old, with newly diagnosed thrombocytopenia during pregnancy

Treatment:

Other: No intervention