NCT04705116 · Pregistry
COVID-19 Vaccines International Pregnancy Exposure Registry
(C-VIPER)
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
COVID-19 vaccine
At least one dose of a COVID-19 vaccine.
Primary outcome measures
Obstetric outcomes
Time frame: 1 year
Number of pregnant women vaccinated against COVID-19 and number of pregnant women not vaccinated against COVID-19 who experience spontaneous abortion, antenatal bleeding, gestational diabetes, gestational hypertension, intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture, placenta previa, chorioamnionitis, Caesarean delivery, or COVID-19.
Neonatal outcomes
Time frame: 1 year
Number of newborns of women vaccinated against COVID-19 and number of newborns of women not vaccinated against COVID-19 during pregnancy who are diagnosed with 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, or COVID-19.
Infant weight
Time frame: 1 year
Change in length and weight from birth to 3, 6, 9, and 12 months of age among newborns of women vaccinated against COVID-19 during pregnancy and among newborns of women not vaccinated against COVID-19 during pregnancy.
Infant developmental milestones
Time frame: 1 year
Change in developmental milestones from baseline at 6, 9, and 12 months based on the tool Caregiver Reported Early Development Instruments among the offspring of women vaccinated against COVID-19 during pregnancy and among offspring of women not vaccinated against COVID-19 during pregnancy.
Infant COVID-19 diagnosis
Time frame: 1 year
Number of newborns of women vaccinated against COVID-19 during pregnancy and number of newborns of women not vaccinated against COVID-19 during pregnancy diagnosed with failure to thrive, medical conditions, or COVID-19 during the first year of life.
Infant height
Time frame: 1 year
Change in height from birth to 3, 6, 9, and 12 months of age among newborns of women vaccinated against COVID-19 during pregnancy and among newborns of women not vaccinated against COVID-19 during pregnancy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 26, 2025 · Source of record for eligibility and locations