Immune Thrombocytopenia in Pregnancy

• Conditions: Immune Thrombocytopenia; Pregnancy

• 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

Study Timeline

• Study Start: 2014-02-03
• Study First Submitted: 2016-07-31
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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