Covid19 Clinical Trial
— PLAN-VOfficial title:
Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination (PLAN-V): Prospective Cohort Study
NCT number | NCT05115617 |
Other study ID # | CTO 3612 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 3, 2021 |
Est. completion date | August 2024 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Sciences Corporation | Hamilton | Ontario |
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Canada | London Health Sciences | London | Ontario |
Canada | The Ottawa Hospital - Civic Campus | Ottawa | Ontario |
Canada | The Ottawa Hospital - General | Ottawa | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario Research Institute, University of Ottawa |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1-month post COVID-19 vaccine | |
Primary | 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. | 3-month, and 6-month post COVID-19 vaccine | |
Primary | 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. | 6-month post COVID-19 vaccine | |
Primary | 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. | At delivery | |
Primary | 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 | 6-months post-COVID-19 vaccine | |
Primary | 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 | 3-month post-COVID-19 vaccine | |
Primary | 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 | 1-month post-COVID-19 vaccine | |
Primary | 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 | During delivery admission | |
Secondary | Maternal death | Maternal death during delivery admission | through study completion, an average of 9 months | |
Secondary | Maternal - Non-delivery hospitalization | Any hospitalization not associated with the delivery of infant. | through study completion, an average of 9 months) | |
Secondary | Any infection | Maternal diagnosis of any infection during pregnancy | through study completion, an average of 9 months | |
Secondary | Pre-term labour | The onset of labour prior to 37 weeks gestation | through study completion, an average of 9 months | |
Secondary | Hypertensive disorders of pregnancy | The diagnosis of a hypertensive disorder of pregnancy | through study completion, an average of 9 months | |
Secondary | Placental abruption | The diagnosis of placental abruption during pregnancy | through study completion, an average of 9 months | |
Secondary | Postpartum hemorrhage | The diagnosis of postpartum hemorrhage | Post-delivery, during the delivery admission | |
Secondary | Preterm birth | Infant born prior to 37 weeks gestation | through study completion, an average of 9 months | |
Secondary | Fetal loss or stillbirth | Fetal loss or stillbirth throughout the pregnancy | through study completion, an average of 9 months | |
Secondary | Small for gestational age | <10th percentile for gestational age and sex- specific birth weight | During the pregnancy, through study completion, an average of 9 months | |
Secondary | Term low birthweight | <2500g | At delivery | |
Secondary | Low 5 min Apgar Score | Score <5 at 5 minutes | At delivery | |
Secondary | Low cord blood pH | cord blood pH<7.0 | At delivery | |
Secondary | admission to neonatal ICU for >12 hours | Infant admission to the neonatal ICU for >12 hours | During delivery admission | |
Secondary | composite neonatal adverse outcome indicator [NAOI] | A composite indicator which includes various neonatal adverse outcomes | At delivery | |
Secondary | Frequency of infection | Number of infections, including but not limited to: influenza, pneumonia, sepsis, acute respiratory infections, gastrointestinal | Postpartum, through study completion, an average of 9 months | |
Secondary | Re-hospitalization rates | Number of re-hospitalizations and emergency visits | Postpartum, through study completion, an average of 9 months | |
Secondary | 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 | Postpartum, through study completion, an average of 9 months | |
Secondary | Infant death | Infant death | Postpartum, through study completion, an average of 9 months |
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