NCT04705116 COVID-19 Vaccines International Pregnancy Exposure Registry
| NCT ID | NCT04705116 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pregistry |
| Condition | Covid19 |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2021-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy with a COVID-19 vaccine. Specifically, the C-VIPER 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 exposed to single (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 days prior to the first day of the last menstrual period to end of pregnancy and their offspring relative to a matched reference group who received no COVID-19 vaccines during pregnancy.
Eligibility Criteria
Inclusion criteria: Vaccinated population: * Pregnant at time of enrollment * Age ≥18 years at time of enrollment * Signed the informed consent form and submitted the baseline module "COVID-19 Vaccination During This Pregnancy" * Received at least one dose of a COVID-19 vaccine during pregnancy or within the 30 days prior to the first day of the LMP * 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 Efforts will be made to obtain documentary evidence of COVID-19 vaccination. Comparison population: * Pregnant at time of enrollment * Age ≥18 years at time of enrollment * Signed the informed consent form and submitted the minimum required data in the initial baseline questionnaire * Have not received a COVID-19 vaccine during pregnancy or within the 30 days prior to the first day of the LMP * Resident of a country where a Central IRB or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study Exclusion criteria: * Not pregnant at time of enrollment * Age \<18 years at time of enrollment
Contact & Investigator
Cheryl Renz, MD
PRINCIPAL INVESTIGATOR
Pregistry
Frequently Asked Questions
Who can join the NCT04705116 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Covid19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04705116 currently recruiting?
Yes, NCT04705116 is actively recruiting participants. Contact the research team at c-viper@pregistry.com for enrollment information.
Where is the NCT04705116 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04705116 clinical trial?
NCT04705116 is sponsored by Pregistry. The principal investigator is Cheryl Renz, MD at Pregistry. The trial plans to enroll 6,000 participants.
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