The current listing reports they are not recruiting trial candidates yet, but their goal is to involve 5,000 participants in the study. The first two years of the study is dedicated to recruiting voluntary women, who will then be separated into two cohorts.
- Cohort 1: pregnant women exposed from 30 days prior to the first day of the LMP (last menstrual period) to end of pregnancy to at least one dose of a COVID-19 vaccine. These participants are enrolled as part of the C-VIPER. (2)
- Cohort 2: pregnant women unexposed to a COVID-19 vaccine before enrollment and had a negative screening test for the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) during pregnancy. (3)
The data collected from both cohorts will be compared to each other to determine the underlying risks associated with pregnant women receiving the COVID-19 vaccine.
What are the risks?
During the third and fourth year of the trial follow-ups of the pregnancies and newborns will occur. Although data will be collected and reported on a continuous basis, these years will be crucial regarding thorough investigations.
The follow-ups are meant to measure the occurrence of pre-determined risks provided by researchers. Within the listing, there is a section dedicated to ‘Primary Outcome Measures’, where the potential risks are listed.
- Potential Obstetric Outcomes: abortion, antenatal bleeding, dysfunctional labor, gestational diabetes, hypertensive disorders of pregnancy, intrauterine growth retardation, maternal death, non-reassuring fetal status, pathways to premature birth, postpartum hemorrhage, or COVID-19.
- Potential Neonatal Outcomes: congenital anomalies, failure to thrive, low birth weight, neonatal death, neonatal encephalopathy, neonatal infections, preterm birth, respiratory distress in the newborn, small for gestational age, stillbirth, or COVID-19.
Who is Pregistry?
Pregistry, the conducting organization, describes themselves as “…a start-up company dedicated to improving maternal and fetal health by the collection, analysis, and sharing of accurate information in support of healthy pregnancies, healthy babies, and successful breastfeeding.”(4)
The Founder and CEO of the organization, Diego Wyszynski, will be leading the clinical trial as the Principal Investigator.
On Dr. Patrick’s show, A Different Perspective, you can find further discussion about the COVID-19 vaccine(s).
Here are some links to get you started: