Study identification

PURI

https://redirect.ema.europa.eu/resource/48094

EU PAS number

EUPAS46841

Study ID

48094

Official title and acronym

Pregistry International Pregnancy Exposure Registry (PIPER)

DARWIN EU® study

No

Study countries

Canada
Nigeria
Philippines
South Africa
United Kingdom
United States

Study 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.

Study status

Planned
Research institutions and networks

Institutions

Pregistry
First published:
01/02/2024
Institution

Contact details

Wyszynski Diego

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pregistry, LLC
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable