COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,184
- 试验地点
- 2
- 主要终点
- Infant height
研究概览
简要总结
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.
详细描述
Rationale and background: COVID-19 vaccines will be used in pregnant populations. Scientific evidence regarding their safety for pregnant women and the developing fetus is lacking.
Objective: The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to 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 (LMP) to end of pregnancy and their offspring relative to a matched reference group who received no COVID-19 vaccines during pregnancy.
Study design: The C-VIPER is an international, non-interventional, post-marketing cohort study designed to collect prospective safety data among women vaccinated with a COVID-19 vaccine during pregnancy or within 30 days prior to the first day of the LMP.
Population: The study population includes 2 cohorts of pregnant women 18 years of age and older matched by country and gestational age (±2 weeks):
- Cohort 1: pregnant women exposed from 30 days prior to the first day of the LMP to end of pregnancy to at least one dose of a COVID-19 vaccine. These participants are enrolled as part of the C-VIPER.
- Cohort 2: pregnant women unexposed to a COVID-19 vaccine during pregnancy. These participants are enrolled through the Pregistry International Exposure Registry (PIPER) with the same methods as those in Cohort 1. Women vaccinated before 30 days prior to the first day of the LMP are eligible for inclusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Not pregnant at time of enrollment
- •Age <18 years at time of enrollment
研究组 & 干预措施
Vaccinated pregnant women
Pregnant women who received at least one dose of a COVID-19 vaccine from 30 days prior to the first day of the LMP to end of pregnancy.
干预措施: COVID-19 vaccine (Biological)
结局指标
主要结局
Infant height
时间窗: 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.
Obstetric outcomes
时间窗: 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
时间窗: 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 COVID-19 diagnosis
时间窗: 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 weight
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点