An observational study in SARS-CoV2 Infection, Covid19 and Vaccine Reaction, sponsored by Ottawa Hospital Research Institute. Recruiting at 7 sites in Canada. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Ottawa Hospital Research Institute · Observational
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.
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:
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 150 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Pregnant individuals who have previously received one-dose of COVID-19 vaccine, or who are planning to receive a COVID-19 vaccine in pregnancy.
Antibody titres in biological samples
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.
Time frame: 1-month post COVID-19 vaccine
Antibody titres in biological samples
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.
Time frame: 3-month, and 6-month post COVID-19 vaccine
Antibody titres in biological samples
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.
Time frame: 6-month post COVID-19 vaccine
Antibody titres in biological samples
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.
Time frame: At delivery
Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
Time frame: 6-months post-COVID-19 vaccine
Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
Time frame: 3-month post-COVID-19 vaccine
Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.
Comparing immune responses to COVID-19 vaccination in pregnant and non-pregnant women/individuals
Time frame: 1-month post-COVID-19 vaccine
Antibody titres in biological samples of pregnant and non-pregnant populations
Comparing infection-acquired and vaccine-acquired immunity against COVID-19 in mothers and newborns
Time frame: During delivery admission
Maternal death
Maternal death during delivery admission
Time frame: through study completion, an average of 9 months
Maternal - Non-delivery hospitalization
Any hospitalization not associated with the delivery of infant.
Time frame: through study completion, an average of 9 months)
Any infection
Maternal diagnosis of any infection during pregnancy
Time frame: through study completion, an average of 9 months
Pre-term labour
The onset of labour prior to 37 weeks gestation
Time frame: through study completion, an average of 9 months
Hypertensive disorders of pregnancy
The diagnosis of a hypertensive disorder of pregnancy
Time frame: through study completion, an average of 9 months
Placental abruption
The diagnosis of placental abruption during pregnancy
Time frame: through study completion, an average of 9 months
Postpartum hemorrhage
The diagnosis of postpartum hemorrhage
Time frame: Post-delivery, during the delivery admission
Preterm birth
Infant born prior to 37 weeks gestation
Time frame: through study completion, an average of 9 months
Fetal loss or stillbirth
Fetal loss or stillbirth throughout the pregnancy
Time frame: through study completion, an average of 9 months
Small for gestational age
\<10th percentile for gestational age and sex- specific birth weight
Time frame: During the pregnancy, through study completion, an average of 9 months
Term low birthweight
\<2500g
Time frame: At delivery
Low 5 min Apgar Score
Score \<5 at 5 minutes
Time frame: At delivery
Low cord blood pH
cord blood pH\<7.0
Time frame: At delivery
admission to neonatal ICU for >12 hours
Infant admission to the neonatal ICU for \>12 hours
Time frame: During delivery admission
composite neonatal adverse outcome indicator [NAOI]
A composite indicator which includes various neonatal adverse outcomes
Time frame: At delivery
Frequency of infection
Number of infections, including but not limited to: influenza, pneumonia, sepsis, acute respiratory infections, gastrointestinal
Time frame: Postpartum, through study completion, an average of 9 months
Re-hospitalization rates
Number of re-hospitalizations and emergency visits
Time frame: Postpartum, through study completion, an average of 9 months
Composite indicator for complex chronic conditions
Composite indicator includes: neurologic and neuromuscular; cardiovascular; respiratory; renal and urologic; gastrointestinal; hematologic or immunologic; metabolic; other congenital or genetic defect; and malignancy
Time frame: Postpartum, through study completion, an average of 9 months
Infant death
Infant death
Time frame: Postpartum, through study completion, an average of 9 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — IPD that underlie the results reported in this article, after deidentification, will be made available to other researchers upon request.
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Ottawa Hospital Research Institute