Immune Thrombocytopenia in Pregnancy

NCT02892630 | Unknown

• 1 other identifier: AOM12204
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia; Pregnancy

Keywords

Immune Thrombocytopenia; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (3)

Pregnant ITP women

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

Other: No intervention

Control ITP Women (Non pregnant)

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

Other: No intervention

De novo ITP pregnant women

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

Other: No intervention

Interventions

No intervention OTHER

Control ITP Women (Non pregnant); De novo ITP pregnant women; Pregnant ITP women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from French referral centers for immune Thrombocytopenia

You may qualify if:

• 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

You may not qualify if:

• Secondary ITP (according to 2009 consensus conference)
• Severe comorbidity making difficult women's following
• 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
• Secondary ITP (according to 2009 consensus conference)
• Severe comorbidity making difficult women's following
• 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, ….
• Secondary ITP (according to 2009 consensus conference)
• Severe comorbidity making difficult women's following
• Non confirmation of ITP diagnosis in post-partum

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 19005182 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.

  PMID: 12041677 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.

  PMID: 12947011 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.

  PMID: 9827911 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.

  PMID: 19846889 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Bertrand Godeau, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand Godeau, PU-PH

CONTACT

(0)1 49 81 29 05; bertrand.godeau@hmn.aphp.fr

Valentine Loustau, CCA

CONTACT

(0)1 49 81 20 76; valentine.loustau@hmn.aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2016
• First Posted: September 8, 2016
• Study Start: February 3, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)