Status:
TERMINATED
Pregistry International Pregnancy Exposure Registry (PIPER)
Lead Sponsor:
Pregistry
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-50 years
Brief Summary
The aims of the Pregistry International Pregnancy Exposure Registry (PIPER) are to provide early signals of risk after prenatal exposure to medical products and to define boundaries of safety for medi...
Detailed Description
Rationale and background: Given the limitations of animal reproductive studies, pre-approval clinical trials in human populations, and post-marketing spontaneous adverse event reports to produce evide...
Eligibility Criteria
Inclusion
- Pregnant at time of enrollment
- Age ≥18 years at time of enrollment
- Signed the informed consent form and submitted the baseline module
- Resident of a country where a Central Institutional Review Board (IRB) or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study
Exclusion
- Not pregnant at time of enrollment
- Age \<18 years at time of enrollment
Key Trial Info
Start Date :
October 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 28 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05352256
Start Date
October 1 2022
End Date
July 28 2025
Last Update
July 31 2025
Active Locations (1)
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1
Pregistry
Los Angeles, California, United States, 90067