Pregistry International Pregnancy Exposure Registry (PIPER)

NCT05352256 | Terminated

• 1 other identifier: PR006
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (5)

• Obstetric outcomes

  Number of pregnant women who experience spontaneous abortion, antenatal bleeding, gestational diabetes, gestational hypertension, intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture, placenta previa, chorioamnionitis, Caesarean delivery, or COVID-19.

  1 year

• Neonatal outcomes

  Number of newborns who are diagnosed with 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, or COVID-19.

  1 year

• Infant weight

  Change in weight from birth to 3, 6, 9, and 12 months of age among newborns.

  1 year

• Infant developmental milestones

  Change in developmental milestones from baseline at 6, 9, and 12 months based on the tool Caregiver Reported Early Development Instruments among the offspring.

  1 year

• Infant length

  Change in length from birth to 3, 6, 9, and 12 months of age among newborns.

  1 year

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Persons assigned gender female at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target study population consists of pregnant women who are 18 years of age and older.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pregistry: lead

Study Sites (1)

Pregistry

Los Angeles, California, 90067, United States

Location

Study Officials

• Diego Wyszynski, MD, MHS, PhD

  Pregistry, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 28, 2022
• Study Start: October 1, 2022
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)