Immune Thrombocytopenia in Pregnancy

Pregnancy Clinical Trial

— TIGRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02892630
• Other study ID #: AOM12204
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2016
• Last updated: October 18, 2017
• Start date: February 3, 2014
• Est. completion date: May 2019

Study information

• Verified date: October 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bertrand Godeau, PU-PH
• Phone: (0)1 49 81 29 05
• Email: bertrand.godeau[@]hmn.aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Pregnancy
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

Fujimura K, Harada Y, Fujimoto T, Kuramoto A, Ikeda Y, Akatsuka J, Dan K, Omine M, Mizoguchi H. Nationwide study of idiopathic thrombocytopenic purpura in pregnant women and the clinical influence on neonates. Int J Hematol. 2002 May;75(4):426-33. — View Citation

Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21. Review. — View Citation

Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kühne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12. — View Citation

Valat AS, Caulier MT, Devos P, Rugeri L, Wibaut B, Vaast P, Puech F, Bauters F, Jude B. Relationships between severe neonatal thrombocytopenia and maternal characteristics in pregnancies associated with autoimmune thrombocytopenia. Br J Haematol. 1998 Nov;103(2):397-401. — View Citation

Webert KE, Mittal R, Sigouin C, Heddle NM, Kelton JG. A retrospective 11-year analysis of obstetric patients with idiopathic thrombocytopenic purpura. Blood. 2003 Dec 15;102(13):4306-11. Epub 2003 Aug 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The biologic worsening is defined by a platelet decrease > 30% compared to platelet count before pregnancy	During 15 months (9 months of pregnancy and 6 months of post partum)
Secondary	Identification of risk factors of ITP worsening during pregnancy		During 15 months
Secondary	Evaluation of obstetrical complications in case of ITP		During 15 months
Secondary	Evaluation of neonatal thrombocytopenia in case of maternal ITP		During 15 months
Secondary	Identification of the risk factors of obstetrical complications		During 15 months
Secondary	Identification of the risk factors of neonatal thrombocytopenia		During 15 months