Pregistry International Pregnancy Exposure Registry (PIPER)

Description

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

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Study Overview

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Study Details

Study overview

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.

Pregistry International Pregnancy Exposure Registry (PIPER)

Pregistry International Pregnancy Exposure Registry (PIPER)

Condition
Pregnancy Related
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Pregistry, Los Angeles, California, United States, 90067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Not pregnant at time of enrollment
  • * Age \<18 years at time of enrollment

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Pregistry,

Diego Wyszynski, MD, MHS, PhD, PRINCIPAL_INVESTIGATOR, Pregistry, LLC

Study Record Dates

2032-04-30