Watching how pregnancy goes for women living with Pompe disease
Follows pregnancies and babies' growth in mothers with Pompe disease.
Plain-language title generated from the registry record
Registry title: Pompe Pregnancy Sub-Registry
Key facts
- Where
- Bonn, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with Pompe disease who are already in the Pompe Registry and are pregnant now or have been pregnant before.
- Sex
- Women only.
- Disease stage
- Women with Pompe disease. The record gives no stage or severity.
- Earlier treatment
- The record sets no treatment requirement. Women can join whether or not they receive Pompe therapy.
Read by machine on 9 November 2026.
Where in Germany
- BonnBonn, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genzyme, a Sanofi Company
- Trial code
- NCT00567073
- Record updated
- 16 April 2026
- Original description
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.Read full original descriptionShow less
A Sub-registry to Observe the Effect of Alglucosidase Alfa or Avalglucosidase Alfa Treatment on Pregnancy and Infant Growth in Women With Pompe Disease
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.
Inclusion: 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: There are no exclusion criteria for this Sub-Registry.