Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination (PLAN-V): Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Antibody titres in biological samples
研究概览
简要总结
The PLAN-V Study is an Ontario-based prospective, longitudinal study that will consist of extensive biosampling and detailed data collection from pregnant women/individuals, who have received the COVID-19 vaccine during their pregnancy, and their infants across the antenatal, delivery and postpartum periods.
详细描述
There is a pressing need for research to answer critical questions about the role of maternal vaccination for protection of the mother-infant dyad, to inform public health recommendations and to support evidence-based decision-making by Canadian families and their care providers.
The investigators' goal is to generate rapid, reliable evidence specific to the immunogenicity and safety of COVID-19 vaccines in the pregnant population. The specific PLAN-V Study objectives are:
- To evaluate immunogenicity of COVID-19 vaccines in pregnant women/individuals and the fetal/newborn immune response to maternal vaccination.
- To evaluate safety of COVID-19 vaccination in pregnant women/individuals based on obstetrical, fetal and newborn health outcomes.
- To compare immune responses to COVID-19 vaccination and natural COVID-19 disease among pregnant women/individuals and their infants exposed in utero
- To compare the immune responses to COVID-19 vaccination between pregnant and non-pregnant women/individuals.
PLAN-V is an Ontario-based prospective, longitudinal study that will consist of extensive biosampling and detailed data collection from pregnant women/individuals and their infants across the prenatal, delivery and postpartum periods. With this approach, detailed participant profiles will be generated that will enable us to explore vaccine reactogenicity; vaccine-associated adverse events; frequency of obstetrical and fetal/newborn outcomes; and measures of infant health and well-being. The study will build on existing resources and expertise available through the COVID-19 Ontario Pregnancy Event (COPE) Network to establish a prospective, longitudinal cohort study of pregnant women/individuals, and their infants.
The PLAN-V Study will consist of pregnant women/individuals who are planning to receive a COVID-19 vaccine(s) at any stage in pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women/Individuals ≥ 16 years of age who are ≥7 0/7 weeks' gestation on the day of enrollment
- •Capacity to provide informed consent and to comprehend and comply with the study requirements
- •Planning to deliver at a participating site hospital
- •Planning to receive or have previously received one-dose of a Health Canada approved COVID-19 vaccine (any product, any number of doses) during the current pregnancy
排除标准
- •Cases with known major fetal concerns
- •Women/Individuals who are fully vaccinated against COVID-19
- •Women/Individuals who are pregnant due to surrogacy, or planning to give their child up for adoption
- •Women/Individuals with a non-viable pregnancy (e.g., ectopic)
结局指标
主要结局
Antibody titres in biological samples
时间窗: At delivery
Immunogenicity of COVID-19 Vaccines: Seroconversion rates in vaccinated mothers, SARS-CoV-2 antibody titres and their persistence in mothers after vaccination in pregnancy, transfer of antibodies to breastmilk/chestmilk, transfer and persistence of SARS-CoV-2 antibodies to the neonate/infant over the study period.
Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
时间窗: 1-month post-COVID-19 vaccine
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
Antibody titres in biological samples of pregnant and non-pregnant populations
时间窗: During delivery admission
Comparing infection-acquired and vaccine-acquired immunity against COVID-19 in mothers and newborns
次要结局
- Low cord blood pH(At delivery)
- Small for gestational age(During the pregnancy, through study completion, an average of 9 months)
- Low 5 min Apgar Score(At delivery)
- admission to neonatal ICU for >12 hours(During delivery admission)
- composite neonatal adverse outcome indicator [NAOI](At delivery)
- Frequency of infection(Postpartum, through study completion, an average of 9 months)
- Maternal - Non-delivery hospitalization(through study completion, an average of 9 months))
- Any infection(through study completion, an average of 9 months)
- Pre-term labour(through study completion, an average of 9 months)
- Postpartum hemorrhage(Post-delivery, during the delivery admission)
- Preterm birth(through study completion, an average of 9 months)
- Re-hospitalization rates(Postpartum, through study completion, an average of 9 months)
- Maternal death(through study completion, an average of 9 months)
- Placental abruption(through study completion, an average of 9 months)
- Fetal loss or stillbirth(through study completion, an average of 9 months)
- Infant death(Postpartum, through study completion, an average of 9 months)
- Hypertensive disorders of pregnancy(through study completion, an average of 9 months)
- Term low birthweight(At delivery)
- Composite indicator for complex chronic conditions(Postpartum, through study completion, an average of 9 months)
研究者
Darine El-Chaâr
Principal Investigator
Ottawa Hospital Research Institute