Description of maternal and neonatal adverse events in pregnant people immunised with COVID-19 vaccines during pregnancy in the CLAP NETWORK of sentinel sites. Nested case-control analysis of the immunization-associated risk: A study protocol.

Publication date: Jan 29, 2024

COVID-19 is associated with higher morbimortality in pregnant people compared with non-pregnant people. At present, the benefits of maternal immunisation are considered to outweigh the risks, and therefore, vaccination is recommended during pregnancy. However, additional information is needed on the safety of the vaccines in this population. This a retrospective cohort nested case-control study in pregnant people who attended maternity hospitals from eight Latin American and Caribbean countries. A perinatal electronic clinical history database with neonatal and obstetric information will be used. The proportion of pregnant people immunised with COVID-19 vaccines of the following maternal and neonatal events will be described: preterm infant, small for gestational age, low birth weight, stillbirth, neonatal death, congenital malformations, maternal near miss and maternal death. Moreover, the risk of prematurity, small for gestational age and low birth weight associated with exposure to COVID-19 vaccines will be estimated. Each case will be matched with two groups of three randomly selected controls. Controls will be matched by hospital and mother’s age (+/-3 years) with an additional matching by delivery date and conception time in the first and second control groups, respectively. The estimated required sample size for the main analysis (exposure to any vaccine) concerning ‘non-use’ is at least 1009 cases (3027 controls) to detect an increased probability of vaccine-associated event risk of 30% and at least 650 cases (1950 controls) to detect 30% protection. Sensitivity and secondary analyses considering country, type of vaccine, exposure windows and completeness of immunisation will be reported. The study protocol was reviewed by the Ethical Review Committee on Research of the Pan American Health Organization. Patient informed consent was waived due to the retrospective design and the utilisation of anonymised data (Ref. No: PAHOERC. 0546. 01). Results will be disseminated in open access journals.

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Concepts Keywords
American COVID-19
Malformations maternal medicine
Maternity perinatology
Stillbirth
Vaccines

Semantics

Type Source Name
disease MESH COVID-19
disease VO immunization
disease VO protocol
disease VO vaccination
disease VO population
disease IDO history
disease MESH infant small for gestational age
disease MESH stillbirth
disease MESH neonatal death
disease MESH malformations
disease MESH maternal death
disease VO time
disease VO vaccine
disease IDO country
disease VO organization
disease VO Sip
drug DRUGBANK Coenzyme M
disease MESH coronavirus infection
disease MESH morbidity
disease VO unvaccinated
disease MESH pre eclampsia
disease MESH miscarriage
disease MESH gestational diabetes
disease MESH complications
disease MESH fetal distress
disease VO effective
disease VO Viruses
disease MESH influenza
disease VO TDAP
disease MESH infection
disease MESH pregnancy outcomes
disease MESH fetal death
disease VO vaccinated
disease VO effectiveness
disease MESH preterm birth
disease VO USA
disease MESH tetanus
disease MESH diphtheria
disease MESH rubella
disease MESH hepatitis
disease MESH hepatitis A
disease VO frequency
disease MESH Live birth
disease MESH Marital status
disease MESH Alcoholism
pathway KEGG Alcoholism
disease MESH High blood pressure
disease MESH Eclampsia
disease VO Comirnaty
disease VO CoronaVac
disease VO dose
disease MESH death
drug DRUGBANK Gold
pathway REACTOME Reproduction
drug DRUGBANK Isoxaflutole
disease VO Canada
drug DRUGBANK Etoperidone
disease VO report
disease VO pregnant women
disease VO efficient
disease MESH Infectious Diseases
disease VO Equity
disease VO coronavirus vaccine
disease MESH pregnancy complications

Original Article

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