Registry to assess risks of medical products during pregnancy
Pregistry International Pregnancy Exposure Registry (PIPER)
Pregistry · NCT05352256
This study looks at the safety of medical products used during pregnancy to see if they might affect the health of mothers and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Pregistry (industry) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05352256 on ClinicalTrials.gov |
What this trial studies
The Pregistry International Pregnancy Exposure Registry (PIPER) aims to identify potential risks associated with prenatal exposure to medical products. This observational study will collect data on various obstetric, neonatal, and infant outcomes to provide early signals of risk and define safety boundaries for these products. By analyzing outcomes such as spontaneous abortion, gestational diabetes, and congenital malformations, the registry seeks to inform prescribers and participants about the implications of prenatal treatments. The study will involve pregnant individuals who consent to participate and provide baseline information.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 years and older who can provide informed consent.
Not a fit: Patients who are not pregnant or under the age of 18 will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance the safety of medical products used during pregnancy, leading to better health outcomes for mothers and their babies.
How similar studies have performed: While there have been similar registries, the specific focus on newer medical products during pregnancy makes this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Not pregnant at time of enrollment * Age \<18 years at time of enrollment
Where this trial is running
Los Angeles, California
- Pregistry — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Diego Wyszynski, MD, MHS, PhD — Pregistry, LLC
- Study coordinator: Diego Wyszynski, MD, MHS, PhD
- Email: hello@pregistry.com
- Phone: 18006163791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy Related