Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2014-02-03
2019-05-31
Brief Summary
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The conclusions of this study will allow us to adapt national guidelines for ITP during pregnancy.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant ITP women
Pregnant women more than 18 years old, with primary ITP diagnosis before pregnancy
No intervention
Control ITP Women (Non pregnant)
Primary ITP women more than 18 years old, at more than one year from a precedent pregnancy
No intervention
De novo ITP pregnant women
Pregnant women more than 18 years old, with newly diagnosed thrombocytopenia during pregnancy
No intervention
Interventions
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No intervention
Eligibility Criteria
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Inclusion Criteria
* Primary ITP diagnosis, defined according to international criteria of 2009 consensus conference (isolated thrombocytopenia \<100 G/L)
* And pregnancy diagnosis after ITP diagnosis
* 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
* 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, ….
Exclusion Criteria
* Severe comorbidity making difficult women's following
* Secondary ITP (according to 2009 consensus conference)
* Severe comorbidity making difficult women's following
* Secondary ITP (according to 2009 consensus conference)
* Severe comorbidity making difficult women's following
* Non confirmation of ITP diagnosis in post-partum
18 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Bertrand Godeau, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Henri Mondor Hospital
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Bertand Godeau, PU-PH
Role: primary
Valentine Loustau, CCA
Role: backup
References
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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, Kuhne 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.
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. doi: 10.1007/BF02982137.
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. doi: 10.1182/blood-2002-10-3317. Epub 2003 Aug 28.
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. doi: 10.1046/j.1365-2141.1998.01006.x.
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.
Other Identifiers
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AOM12204
Identifier Type: -
Identifier Source: org_study_id