Tracking pregnancy outcomes in women with Pompe disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Sub-registry is a multicenter, international, longitudinal program that observes pregnancy outcomes for women enrolled in the Pompe Registry. It includes women regardless of whether they are receiving disease-specific therapy for Pompe disease. The study collects data on pregnancy complications and infant growth, allowing for both retrospective and prospective assessments. Participants undergo clinical evaluations and receive standard care as determined by their healthcare providers.

Why it matters

Who can join: the full rules

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

Where it's running

• Barrow Neurol Group- Site Number : 840087
  Phoenix, Arizona, United States Recruiting
• University of Florida Pediatrics Genetics- Site Number : 157138
  Jacksonville, Florida, United States Recruiting
• Emory University School Of Medicine- Site Number : 840060
  Atlanta, Georgia, United States Recruiting
• Indianapolis University School of Medicine- Site Number : 840027
  Indianapolis, Indiana, United States Recruiting
• University of Iowa- Site Number : 150294
  Iowa City, Iowa, United States Recruiting
• Spectrum for Health- Site Number : 840019
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free number for US & Canada)
• Email: Contact-us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.