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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant ITP women | Pregnant women more than 18 years old, with primary ITP diagnosis before pregnancy |
| |
| Control ITP Women (Non pregnant) | Primary ITP women more than 18 years old, at more than one year from a precedent pregnancy |
| |
| De novo ITP pregnant women | Pregnant women more than 18 years old, with newly diagnosed thrombocytopenia during pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of risk factors of ITP worsening during pregnancy | During 15 months | |
| Evaluation of obstetrical complications in case of ITP | During 15 months | |
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Pregnant ITP women Inclusion Criteria
Control ITP Women (Non pregnant) Inclusion Criteria
De novo ITP pregnant women Inclusion Criteria
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Patients from French referral centers for immune Thrombocytopenia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertrand Godeau, PU-PH | Contact | (0)1 49 81 29 05 | +33 | bertrand.godeau@hmn.aphp.fr |
| Valentine Loustau, CCA | Contact | (0)1 49 81 20 76 | +33 | valentine.loustau@hmn.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bertrand Godeau, PU-PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Recruiting | Créteil | 94010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19005182 | Background | 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. | |
| 12041677 |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| 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 |
| Background |
| 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. |
| 12947011 | Background | 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. |
| 9827911 | Background | 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. |
| 19846889 | Background | 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. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |