Promacta Pregnancy Registry

Study Overview
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Brief Summary
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Since Idiopathic Thrombocytopenic Purpura (ITP) affects women who are of reproductive capacity and taking into account the lack of data concerning Eltrombopag (Promacta) use during pregnancy, the Eltrombopag (Promacta) Registry will be an essential component of the ongoing risk management for Eltrombopag (Promacta). The Registry will detect and record the events (live births, spontaneous abortions, stillbirths, elective terminations, therapeutic terminations, any serious pregnancy outcome, major and minor congenital anomalies, outcomes including preterm, small for gestation age, or intrauterine growth restriction adverse adverse effects on the following: immune system development, platelet number and function, neoplasm formation, bone marrow reticulin formation, thrombotic events) in the mother and/or the neonate/infant. The adverse events in the infant will be assessed through at least the first year of life. The Pregnancy Registry will compare the pregnancy and fetal outcomes of women exposed to eltrombopag Tablets during pregnancy to an unexposed control population. This study will be a prospective observational, exposure follow-up study.

Detailed Description
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The outcomes of pregnancy are: live births, spontaneous abortions, stillbirths, elective terminations, therapeutic terminations, any serious pregnancy outcome, major and minor congenital anomalies, outcomes including preterm, small for gestation age, or intrauterine growth restriction adverse effects on the following: immune system development, platelet number and function, neoplasm formation, bone marrow reticulin formation, thrombotic events in the mother and/or the neonate/infant.

Official Title
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Promacta Pregnancy Registry

Conditions
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Purpura, Thrombocytopaenic, Idiopathic

Intervention / Treatment
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* Drug: Eltrombopag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documentation that Eltrombopag is being taken during pregnancy. Timing of the prenatal exposure to Eltrombopag (i.e. best estimation of which trimester in pregnancy that there was exposure to Eltrombopag for stratification and reporting purposes). Sufficient information to determine whether the pregnancy is being prospectively or retrospectively registered. Whether the outcome of pregnancy was known at the time of the report. Source of the report (i.e. health care professional, patient). Full provider contact information to allow for follow-up (name, address, etc.) Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women on eltrombopag<br>Any women with eltrombopag exposure during pregnancy that is reported prior to or after knowledge of the pregnancy outcome, substantiated by health care provider, and meeting the enrollment criteria: documentation that eltrombopag is being taken during pregnancy; timing of the prenatal exposure to eltrombopag (i.e. best estimation of which trimester in pregnancy that there was exposure to Eltrombopag for stratification and reporting purposes ); sufficient information to determine whether the pregnancy is being prospectively or retrospectively registered; whether the outcome of pregnancy was known at the time of the report; source of the report (i.e. health care professional, patient); full provider contact information to allow for follow-up (name, address, etc.) | Drug: Eltrombopag<br>* Eltrombopag is an orally bioavailable, small molecule thrombopoietin receptor (TPO-R) agonist for the treatment of idiopathic thrombocytopenic purpura<br>|
| Infants<br>Infants through the first year of life whose mothers were exposed to eltrombopag during pregnancy. | Drug: Eltrombopag<br>* Eltrombopag is an orally bioavailable, small molecule thrombopoietin receptor (TPO-R) agonist for the treatment of idiopathic thrombocytopenic purpura<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of Pregnancy (see Detailed Description for a complete list) |  | From exposure during pregnancy through at least the first year of infant's life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombocytopenia, Pregnancy