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Pompe Pregnancy Sub-Registry

Recruitingn/aAges any - anyFemaleGenzyme, a Sanofi Company
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In plain words

What the trial is, and whether it could suit you

This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Pompe Registry, regardless of whether she is receiving disease-specific therapy (such as ERT with alglucosidase alfa or avalglucosidase alfa) and irrespective of the commercial product with which she may be treated. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Pompe disease during pregnancy, regardless of whether they receive disease-specific therapy, such as ERT with alglucosidase alfa or avalglucosidase alfa.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Eligible women must: * be enrolled in the Pompe registry (NCT00231400) * be pregnant, or have been pregnant with appropriate medical documentation available. * provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed. Note: It is recommended that pregnancy data be collected on eligible women regardless of infant enrollment. In the event of patients having multiple pregnancies, participation in this Sub-Registry is encouraged for each individual pregnancy. Exclusion Criteria: There are no exclusion criteria for this Sub-Registry
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What it tests

  • Not listed
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Where

35 sites
Barrow Neurol Group- Site Number : 840087
Phoenix, United States
University of Florida Pediatrics Genetics- Site Number : 157138
Jacksonville, United States
Emory University School Of Medicine- Site Number : 840060
Atlanta, United States
Indianapolis University School of Medicine- Site Number : 840027
Indianapolis, United States
University of Iowa- Site Number : 150294
Iowa City, United States
Spectrum for Health- Site Number : 840019
Grand Rapids, United States
Washington University- Site Number : 150612
St Louis, United States
New York University School Of Medicine- Site Number : 840040
New York, United States

โ€ฆand 27 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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