Table 1.
Key variables collected by the C-VIPER and the PIPER
| Baseline module | COVID-19 vaccine modulea | Pregnancy follow-up and birth outcome modules | Infant follow-up modules |
|---|---|---|---|
| Date of study enrollment | Date of vaccination | Single/multiple pregnancy | Sex of infant |
| Gestational age at time of enrollment, as measured in weeks from first day of last menstrual period | Gestational age at time of vaccination by dose | New or recurrent medical conditions at any time during pregnancy, except adverse events following vaccination | Neonatal/infant death |
| Maternal age in years | Number of COVID-19 vaccination doses received and whether during pregnancy | Start and end dates of medical conditions | Birthweight |
| Country and continent of residence | Manufacturer of each COVID-19 vaccine dose | Outcome of medical conditions | Admission to neonatal intensive care unit; length of stay |
| Maternal race/ethnicity | Batch/lot number of each COVID-19 vaccine dose | Severity of medical conditions | Major congenital malformation |
| Maternal education level | Adverse events within 48 h of vaccination | Pregnancy-related medical conditions | Genetic/inherited disorder |
| Maternal employment status | Start and end dates of adverse events | Pregnancy outcome | Other infant outcomes |
| Healthcare coverage at onset of pregnancy | Outcome of adverse events | Other obstetric outcomes | Feeding method |
| Number of previous pregnancies | Severity of adverse events | Gestational age at delivery | Duration of breastfeeding |
| Number of previous live births | Pre-existing conditions affecting immune response | Preterm labor; reason | Infant vaccinations |
| Number of previous stillbirths | Other non-COVID-19 vaccines received in 4 weeks prior to COVID-19 vaccine | Mode of delivery | Variables repeated at 3, 6, 9, and 12 months: |
| Number of previous ectopic or tubal pregnancies | Intensive care unit admission during/after delivery | Infant’s weight | |
| Number of previous miscarriages | Medication use during pregnancy | Infant’s length | |
| Number of previous elective terminations | Adverse events in mother and baby | Infant medical conditions | |
| Self-reported pre-pregnancy health status | Adverse events in mother and baby | ||
| High-risk pregnancy as assessed by healthcare professional | Variables repeated at 6, 9, and 12 months: | ||
| Pre-existing medical conditions | Standardized motor development score | ||
| History of COVID-19 infection | Standardized cognitive development score | ||
| Tobacco use | Standardized language development score | ||
| Use of e-cigarettes/other vaping products | Standardized social/emotional development score | ||
| Recreational drug use | Standardized total development score | ||
| Alcohol use during first 3 months of pregnancy | |||
| Vitamin use during first 3 months of pregnancy | |||
| Medication use at enrollment | |||
| Maternal exposure to known human teratogen during pregnancy | |||
| Antenatal screening at enrollment | |||
| Intended pregnancy | |||
| Use of fertility procedures | |||
| Maternal height | |||
| Maternal pre-pregnancy weight | |||
| Maternal pre-pregnancy body mass index | |||
| Due date |
The bold values indicate that the variables listed below are collected at various points in time (e.g., at 3, 6, 9, and 12 months of the baby's age). The variables not listed under the bold values are collected once
COVID-19 coronavirus disease 2019, C-VIPER COVID-19 Vaccines International Pregnancy Registry, PIPER Pregistry International Pregnancy Exposure Registry
aThis module was administered to the C-VIPER cohort only