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Pregistry International Pregnancy Exposure Registry (PIPER)

NCT05352256 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-07-31

No results posted yet for this study

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 medical products. The goal is to assist prescribers and study participants in weighing the potential risks of prenatal treatments on the wellbeing of mother and the unborn offspring.

Specifically, the PIPER will estimate the risk of obstetric outcomes (spontaneous abortion, antenatal bleeding, gestational diabetes, gestational hypertension, intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture, placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes (major congenital malformations, low birth weight, neonatal death, neonatal encephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth, respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19), and infant outcomes (developmental milestones \[motor, cognitive, language, social-emotional, and mental health skills\], height, weight, failure to thrive, medical conditions during the first 12 months of life, COVID-19) among pregnant women.

Conditions

  • Pregnancy Related

Sponsors & Collaborators

  • Pregistry

    lead INDUSTRY

Principal Investigators

  • Diego Wyszynski, MD, MHS, PhD · Pregistry, LLC

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-07-28
Completion
2025-07-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05352256 on ClinicalTrials.gov