Immune Thrombocytopenia in Pregnancy (TIGRO)

October 18, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients from French referral centers for immune Thrombocytopenia

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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
During 15 months (9 months of pregnancy and 6 months of post partum)

Secondary Outcome Measures

Outcome Measure
Time Frame
Identification of risk factors of ITP worsening during pregnancy
Time Frame: During 15 months
During 15 months
Evaluation of obstetrical complications in case of ITP
Time Frame: During 15 months
During 15 months
Evaluation of neonatal thrombocytopenia in case of maternal ITP
Time Frame: During 15 months
During 15 months
Identification of the risk factors of obstetrical complications
Time Frame: During 15 months
During 15 months
Identification of the risk factors of neonatal thrombocytopenia
Time Frame: During 15 months
During 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Bertrand Godeau, PU-PH, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2014

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

July 31, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM12204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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