Pompe Pregnancy Sub-Registry

Launched by GENZYME, A SANOFI COMPANY · Dec 1, 2007

Keywords

ClinConnect Summary

**Summary of the Pompe Pregnancy Sub-Registry**

The Pompe Pregnancy Sub-Registry is a study aimed at understanding how pregnancy affects women with Pompe disease, which is a rare genetic condition that can lead to muscle weakness. This program tracks the experiences and outcomes of pregnant women who are already part of the Pompe Registry, whether or not they are receiving specific treatments for their condition. The goal is to gather important information about any complications during pregnancy and how the babies grow after birth. No new treatments or drugs will be given; instead, participants will receive the usual care from their doctors.

To join this study, women must be enrolled in the Pompe Registry and currently be pregnant, or have been pregnant in the past, with the necessary medical documentation. They need to agree to participate by signing consent forms. It's important to note that there are no exclusions based on health conditions, so any woman who meets the criteria can participate. This study is a valuable opportunity for women with Pompe disease to contribute to our understanding of how their condition interacts with pregnancy, helping improve care and outcomes for others in the future.

Gender

FEMALE

Eligibility criteria

• 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