Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study
- Conditions
- SARS-CoV2 InfectionImmunogenicityCovid19Vaccine ReactionPregnancy Related
- Registration Number
- NCT05115617
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
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.
- Detailed Description
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:
1. To evaluate immunogenicity of COVID-19 vaccines in pregnant women/individuals and the fetal/newborn immune response to maternal vaccination.
2. To evaluate safety of COVID-19 vaccination in pregnant women/individuals based on obstetrical, fetal and newborn health outcomes.
3. To compare immune responses to COVID-19 vaccination and natural COVID-19 disease among pregnant women/individuals and their infants exposed in utero
4. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antibody titres in biological samples 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. 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 During delivery admission Comparing infection-acquired and vaccine-acquired immunity against COVID-19 in mothers and newborns
- Secondary Outcome Measures
Name Time Method Small for gestational age During the pregnancy, through study completion, an average of 9 months \<10th percentile for gestational age and sex- specific birth weight
Low 5 min Apgar Score At delivery Score \<5 at 5 minutes
admission to neonatal ICU for >12 hours During delivery admission Infant admission to the neonatal ICU for \>12 hours
composite neonatal adverse outcome indicator [NAOI] At delivery A composite indicator which includes various neonatal adverse outcomes
Frequency of infection Postpartum, through study completion, an average of 9 months Number of infections, including but not limited to: influenza, pneumonia, sepsis, acute respiratory infections, gastrointestinal
Maternal - Non-delivery hospitalization through study completion, an average of 9 months) Any hospitalization not associated with the delivery of infant.
Any infection through study completion, an average of 9 months Maternal diagnosis of any infection during pregnancy
Pre-term labour through study completion, an average of 9 months The onset of labour prior to 37 weeks gestation
Postpartum hemorrhage Post-delivery, during the delivery admission The diagnosis of postpartum hemorrhage
Preterm birth through study completion, an average of 9 months Infant born prior to 37 weeks gestation
Re-hospitalization rates Postpartum, through study completion, an average of 9 months Number of re-hospitalizations and emergency visits
Maternal death through study completion, an average of 9 months Maternal death during delivery admission
Placental abruption through study completion, an average of 9 months The diagnosis of placental abruption during pregnancy
Fetal loss or stillbirth through study completion, an average of 9 months Fetal loss or stillbirth throughout the pregnancy
Infant death Postpartum, through study completion, an average of 9 months Infant death
Hypertensive disorders of pregnancy through study completion, an average of 9 months The diagnosis of a hypertensive disorder of pregnancy
Term low birthweight At delivery \<2500g
Low cord blood pH At delivery cord blood pH\<7.0
Composite indicator for complex chronic conditions Postpartum, through study completion, an average of 9 months Composite indicator includes: neurologic and neuromuscular; cardiovascular; respiratory; renal and urologic; gastrointestinal; hematologic or immunologic; metabolic; other congenital or genetic defect; and malignancy
Trial Locations
- Locations (7)
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Hamilton Health Sciences Corporation
🇨🇦Hamilton, Ontario, Canada
The Ottawa Hospital - General
🇨🇦Ottawa, Ontario, Canada
The Ottawa Hospital - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
London Health Sciences
🇨🇦London, Ontario, Canada