Immune ThrombocytopeniaTIGRONCT02892630
Immune Thrombocytopenia in Pregnancy
An observational study of Immune Thrombocytopenia and Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Immune Thrombocytopenia, Pregnancy
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2014to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients from French referral centers for immune Thrombocytopenia
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Henri Mondor Hospital
Créteil, 94010
Bertand Godeau, PU-PH, (0)1 49 81 29 05 ext. +33, bertrand.godeau@hmn.aphp.fr
Valentine Loustau, CCA, (0)1 49 81 20 76 ext. +33, valentine.loustau@hmn.aphp.fr
About this study
Official title: Immune Thrombocytopenia in Pregnancy: Evolution and Prognostic Factors According to a Prospective Observational Comparative Multicenter National French Study
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
- Being tested
- No intervention
- Keywords
- Immune Thrombocytopenia, Pregnancy
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Pregnant ITP women | Pregnant women more than 18 years old, with primary ITP diagnosis before pregnancy Receives: 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 Receives: Other: No intervention | |
| De novo ITP pregnant women | Pregnant women more than 18 years old, with newly diagnosed thrombocytopenia during pregnancy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During 15 months
Evaluation of obstetrical complications in case of ITP
Measured: During 15 months
Evaluation of neonatal thrombocytopenia in case of maternal ITP
Measured: During 15 months
Identification of the risk factors of obstetrical complications
Measured: During 15 months
Identification of the risk factors of neonatal thrombocytopenia
Measured: During 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start3 Feb 2014
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Godeau, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892630
- Sponsor's protocol ID
- AOM12204
- Acronym
- TIGRO
- Status last verified
- Oct 2017
- First submitted
- 31 Jul 2016
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19005182Fujimura 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.
PubMed 12041677Webert 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.
PubMed 12947011Valat 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.
PubMed 9827911Provan 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.
PubMed 19846889
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Thrombocytopenia in Pregnancy: Evolution and Prognostic Factors According to a Prospective Observational Comparative Multicenter National French Study
- ClinicalTrials.gov ID
- NCT02892630
- Acronym / sponsor ID
- TIGRO / AOM12204
- Conditions
- Immune Thrombocytopenia, Pregnancy
- Keywords
- Immune Thrombocytopenia, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Feb 2014 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant ITP women | – | Other: No interventionPregnant women more than 18 years old, with primary ITP diagnosis before pregnancy |
| Control ITP Women (Non pregnant) | – | Other: No interventionPrimary ITP women more than 18 years old, at more than one year from a precedent pregnancy |
| De novo ITP pregnant women | – | Other: No interventionPregnant women more than 18 years old, with newly diagnosed thrombocytopenia during pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from French referral centers for immune Thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Control ITP Women (Non pregnant), De novo ITP pregnant women, Pregnant ITP women |
Primary outcome
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
Time frame: 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
5 secondary outcomes
Identification of risk factors of ITP worsening during pregnancy
Time frame: During 15 months
Evaluation of obstetrical complications in case of ITP
Time frame: During 15 months
Evaluation of neonatal thrombocytopenia in case of maternal ITP
Time frame: During 15 months
Identification of the risk factors of obstetrical complications
Time frame: During 15 months
Identification of the risk factors of neonatal thrombocytopenia
Time frame: During 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Background: PubMed 19005182Rodeghiero 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.
- Background: PubMed 12041677Fujimura 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.
- Background: PubMed 12947011Webert 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.
- Background: PubMed 9827911Valat 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.
- Background: PubMed 19846889Provan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Godeau, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia and Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand Godeau, PU-PH ((0)1 49 81 29 05 ext. +33, bertrand.godeau@hmn.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: During 15 months (9 months of pregnancy and 6 months of post partum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02892630, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.