TERMINATED

Pregistry International Pregnancy Exposure Registry (PIPER)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pregistry International Pregnancy Exposure Registry (PIPER)

Quick Facts

Study Start:2022-10-01
Study Completion:2025-07-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05352256

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant at time of enrollment
  2. * Age ≥18 years at time of enrollment
  3. * Signed the informed consent form and submitted the baseline module
  4. * 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
  1. * Not pregnant at time of enrollment
  2. * Age \<18 years at time of enrollment

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Pregistry
Los Angeles, California, 90067
United States

Collaborators and Investigators

Sponsor: Pregistry

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2025-07-28

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2025-07-28

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy Related