Pregistry, a maternal health, continues to bridge the gap between big pharma and people by evaluating outcomes among women vaccinated during pregnancy with a COVID-19 vaccine.
“The opportunity to launch a study that has such a deep impact on the global health of pregnant women and children is a definingmoment and Pregistry was founded for this very reason,” said Dr. Diego Wyszynski.
Pregistry recently announced the start of the COVID-19 Vaccines International Pregnancy Exposure Registry [CVIPER], designed to identify the risk of common obstetric, neonatal, and infant outcomes among pregnant women around the world who received the COVID-19 vaccine. Pregistry counts as an emerging leader in developing and executing post-approval studies to assess the safety of medications and vaccines used during pregnancy and lactation.C-VIPER is led by principal investigator Dr. Diego
Wyszynski, a renowned perinatal epidemiologist and the CEO of Pregistry.
The study, launched worldwide in June, collects prospective information from volunteer participants that have been vaccinatedduring pregnancy or within 30 days before the first day of their last menstrual period. The study population includes two cohorts of pregnant women 18 years of age and older matched by country and gestational age.
“We look forward to not only delivering vaccination data but also fostering a global pregnancy community for women worldwide,”Dr. Wyszynski said.
The total duration of the C-VIPER study will be five years. Obstetric, neonatal and infant outcomes will be assessed on an ongoing basis as data becomes available. The first two years will consist of, primarily, enrollment of pregnancies, the third and fourth years will involve follow up of pregnancies and newborns, and the final year will be dedicated to completing data analyses and publications. Results on pregnancy and neonatal outcomes, even preliminary, are expected within the first year of the study. Quarterly interim reports including pregnancy, neonatal and infant outcomes will be submitted to the Scientific Advisory Committee andregulatory agencies for their review and feedback.
Results of the C-VIPER study will be published periodically on the Pregistry website and in peer–reviewed medical journals. The external Scientific Advisory Committee guarantees that all data isfree of external influence, transparent, and of the highest scientific rigor. A final report will be prepared at the end of the study.
Learn more about the study at c-viper.pregistry.com or visit https://www.pregistry.com.